MRI Coil MN - doctordoctor.biz

1 P E R I P H E R A L I N T E R V E N T I O N S O R D E R I N G I N F O R M A T I O NTableofContentsOrder NumberProduct NameQuantityper BoxDescriptionMax Diameter (mm)Unrestrained Coil Length (mm)Length in Introducer (mm)M00138220306 ORT8 $IAMOND 16 ORT8 $IAMOND $IAMOND 16 ORT8 $IAMOND $IAMOND 16 ORT8 $IAMOND $IAMOND 16 ORT8 $IAMOND $IAMOND 56 ORT8 $IAMOND $IAMOND 56 ORT8 $IAMOND $IAMOND 56 ORT8 $IAMOND $IAMOND 56 ORT8 $IAMOND Diamond -18 Pushable coils / Vorschiebbare Spiralen / coils pousser / coils empujablesOrder NumberProduct NameQuantityper BoxDescriptionMax Diameter(mm)Unrestrained Coil Length (mm)Length in Introducer (mm)M00138120306 ORT8 16 ORT8 22 M00138120406 ORT8 16 ORT8 MM4 4 42 M00138120506 ORT8 16 ORT8 MM5 60 M00138120606 ORT8 16 ORT8 MM6 M00138120316 ORT8 56 ORT8 MM3 22 M00138120416 ORT8 56 ORT8 MM4 4 42 M00138120516 ORT8 56 ORT8 MM5 60 M00138120616 ORT8 56 ORT8 MM6 85 VortX -18 Pushable coils / Vorschiebbare Spiralen / coils pousser / coils empujablesOrder NumberProduct NameQuantityper BoxDescriptionMax Diameter(mm)Unrestrained Coil Length (mm)Length in Introducer (mm)

2 M00131200203 TRAIGHT 13 TRAIGHT MM3 TRAIGHT22M00131200503 TRAIGHT 13 TRAIGHT MM3 TRAIGHT55M00131200213 TRAIGHT 53 TRAIGHT MM3 TRAIGHT22M00131200513 TRAIGHT 53 TRAIGHT MM3 TRAIGHT55 Straight -18 Pushable coils / Vorschiebbare Spiralen / coils pousser / coils empujablesOrder NumberProduct NameQuantityper BoxDescriptionMax Diameter(mm)Unrestrained Coil Length (mm)Length in Introducer (mm)M0013120210&IGURE 1&IGURE MM2510M0013120211&IGURE 5&IGURE MM2510 Figure 8 -18 Pushable coils / Vorschiebbare Spiralen / coils pousser / coils empujables %MBOLIC !GENTS /CCLUSION "ALLOONSP E R I P H E R A L I N T E R V E N T I O N S O R D E R I N G I N F O R M A T I O NTableofContentsOrder NumberProduct NameQuantityper BoxDescriptionMax Diameter (mm)Unrestrained Coil Length (mm)Length in Introducer (mm)M0013120430 &IGURE 1-ULTI ,OOP MM4730M0013120431&IGURE 5-ULTI ,OOP MM4730 Multi-Loop -18 Pushable coils / Vorschiebbare Spiralen / coils pousser / coils empujablesOrder NumberProduct NameQuantityper BoxDescriptionMax Diameter (mm)Unrestrained Coil Length (mm)Length in Introducer (mm)

3 M0013120220#OMPLEX (ELICAL MM 1#OMPLEX (ELICAL MM4420M0013120330#OMPLEX (ELICAL MM 1#OMPLEX (ELICAL MM6630M0013120440#OMPLEX (ELICAL MM 1#OMPLEX (ELICAL MM71040M0013120550#OMPLEX (ELICAL MM 1#OMPLEX (ELICAL MM81250M0013120660#OMPLEX (ELICAL MM 1#OMPLEX (ELICAL MM101460M0013120770#OMPLEX (ELICAL MM 1#OMPLEX (ELICAL MM111770M0013120221#OMPLEX (ELICAL MM 5#OMPLEX (ELICAL MM4420M0013120331#OMPLEX (ELICAL MM 5#OMPLEX (ELICAL MM6630M0013120441#OMPLEX (ELICAL MM 5#OMPLEX (ELICAL MM71040M0013120551#OMPLEX (ELICAL MM 5#OMPLEX (ELICAL MM81250M0013120661#OMPLEX (ELICAL MM 5#OMPLEX (ELICAL MM101460M0013120771#OMPLEX (ELICAL MM 5#OMPLEX (ELICAL MM111770 Complex Helical -18 Order NumberProduct NameQuantityper BoxDescriptionMax Diameter (mm)Unrestrained Coil Length (mm)Length in Introducer (mm)M0013723020 $ 1 $ (ELICAL #OIL $ 1 $ (ELICAL #OIL $ 1 $ (ELICAL #OIL $ 1 $ (ELICAL #OIL $ 1 $ (ELICAL #OIL 50M0013726040 $ 1 $ (ELICAL #OIL 40M0013727040 $ 1 $ (ELICAL #OIL 40M0013729060 $ 1 $ (ELICAL #OIL 60M0013723021 $ 5 $ (ELICAL #OIL 20M0013723041 $ 5 $ (ELICAL #OIL 40M0013724031 $ 5 $ (ELICAL #OIL 30M0013725031 $ 5 $ (ELICAL #OIL 30M0013725051 $ 5 $ (ELICAL #OIL 50M0013726041 $ 5 $ (ELICAL #OIL 40M0013727041 $ 5 $ (ELICAL #OIL 40M0013729061 $ 5 $ (ELICAL #OIL 602D Helical -35 Pushable coils / Vorschiebbare Spiralen / coils pousser / coils empujablesP E R I P H E R A L I N T E R V E N T I O N S O R D E R I N G I N F O R M A T I O NTableofContentsOrder NumberTotal Length(mm))))))))))))))))))))))))))))))) ))))))))))

4 Outer Diametre (in / mm)Distal Top Outer Diametre(in / mm) M0014012160177 Coil Pusher 16 Order NumberSize( m)Volume (ml)Syringues / BoxM001761132 NumberProduct NameQuantityper BoxDescriptionMax Diameter (mm)Unrestrained Coil Length (mm)Length in Introducer (mm)M0013732040 6 ORT8 16 ORT8 MM4430M0013733050 6 ORT8 16 ORT8 6 ORT8 16 ORT8 6 ORT8 16 ORT8 6 ORT8 56 ORT8 MM4430M0013733051 6 ORT8 56 ORT8 6 ORT8 56 ORT8 6 ORT8 56 ORT8 -35 Pushable coils / Vorschiebbare Spiralen / coils pousser / coils empujablesContour SEMicrospheres / Embolisationssph ren / Particules d'embolisation / Part culas de embolizaci n %MBOLIC !GENTS /CCLUSION "ALLOONSP E R I P H E R A L I N T E R V E N T I O N S O R D E R I N G I N F O R M A T I O NTableofContentsOrder NumberVials per BoxParticle Size Range ( m)M0017600121 2 M0017600151 5 M0017600221 2 M0017600251 5 M0017600321 2 M0017600351 5 M0017600421 2 M0017600451 5 M0017600621 2 M0017600651 5 M0017600821 2 M0017600851 5 M0017601151 5 Order NumberCatheter Size(F / mm) LumensUsable Length(cm)Recommended Guidewire (in / mm)Inflated Balloon Diameter (mm)

5 M001173010 2 80 *Berenstein Occlusion Balloon Catheter is approved for use with microcatheters and embolics *Der Berentstein Okklusions Ballon ist Katheter zugelassen f r die Nutzung mit Mikrokathertern und embolische Produkten *El cat ter Bal n de Oclusi n Berentein es aprobado para su utilizaci n con Microcat teres y material embolizante*Le catheter ballon occlusif Berenstein est approuv pour l utilisation avec des microcatheters et des agents d embolisationContour PVAE mbolisation Particles / PVA Embolisationspartikel / Particules d'embolisation / Part culas de embolizaci n BerensteinOcclusion Balloon Catheters (Large Lumen)* / Okklusions-Ballonkatheter (gro es Lumen)*Cath ters d'occlusion ballonnet (grande lumi re)* / Cat ter de bal n de oclusi n tipo Berenstein (lumen grande)*Order NumberCatheter Size(F / mm) LumensUsable Length(cm)Recommended Guidewire (in / mm)Inflated Balloon Diameter (mm)M001171020 2 65 2 100 Balloons Standard Occlusion Balloon Catheters / Standard Okklusions-Ballonkatheter / Cath ters d'occlusion ballonnet standard Cat teres de bal n de oclusi n est ndarFEB 11 20 HiSection 2 510(k) Summary(Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990)Boston Scientific CorporationSubmitter's Name and Address One Scimed PlaceMaple Grove, MN 55311 Debbie MclntireSenior Regulatory Affairs SpecialistContact Person Boston (J~ : (408) 935-4679 Fax.)

6 (763) 494-2222 Classification Name Vascular enmholization deviceProduct Code KRD1) Fibered Platinum CoilsCommon or Usual Name 2) Fibered Platinum Coils1 ) VortX- I8TM , VortXM Diamond -18, Straight-18, Figure 8-18, Multi-Loop-i18, ComplexProprietary Name Helical- IS Fibered Platinum Coil2) VortXTM-35, 2D Helical-35 Fibered PlatinumCoils1) Target Therapeutics Peripheral coils (K9 14786)Names of Predicate Devices2) Target Therapeutics Fibered Platinum coils (K955293)Reasn fr SumisionModifications to the device labeling related toReasn fr SumisionMRI ) Boston Scientific's 18 Fibered PlatinumCoils consist of platinum-tungsten alloy coilswith synthetic fibers and are available in sixdifferent shapes; Vortx, Vortx Diamond,Complex Helical, Figure-8, Multi-Loop andStraight.

7 The coil is provided with anintroducer that is secured at both ends by aretaining clip during shipping and coil plunger, supplied with the coil, isused to push the coil out of the introducer andDevice Description into the ) Boston Scientific VortX-35 and 2D Helical-35 Fibered Platinum coils are helically-shapedplatinum-tungstent alloy coils with syntheticfibers. The coils are provided with anintroducer that is secured at both ends by aretaining clip during shipping and storage. AcoilI plunger, supplied with the coil, is used topush the coil out of the introducer and into Scientific's 18 and FiberedIntended Use Platinum coils are intended for arterial and venousembolizations in the peripheral testing demonstrates that the Vortx-18, Vortx Diamond-iS, Straight-IS8, Figure 8-18,Multi-Loop-iS, Complex Helical-IS, Vortx-35 and2D Helical-35 Fibered Platinum coils will notpresent additional risk to a patient during a MMIprocedure in comparison to risks imposed bygravitational, and other normal daily activities, or atemperature rise that is experienced during afeverish condition.

8 The results of testingNon-Clinical and Clinical Test conducted under methods described by ASTMS ummary F2182-09, ASTM F2052-06e1, ASTM F2213-06and ASTM F2 119-07 have demonstrated that theCoils are MR Conditional and can be scannedsafely under a static magnetic field of Tesla Tesla in normal operating mode,and in a staticmagnetic field gradient less than 25 at field strengths other than Tesla or 3 Tesla has not been performed to evaluate coil_____ migration or heatingDate prepared. September 2010