VortX Diamond -18. VortX -18. Straight -18. Figure 8-18 O R D E R I N G I N F O R M A T I O N

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1 VortX Diamond -18 M M M M M M M M VortX -18 M M M M M M M M Straight -18 M M M M Figure 8-18 M M

2 Multi-Loop -18 M M Complex Helical -18 M M M M M M M M M M M M D Helical -35 M M M M M M M M M M M M M M M M

3 VortX -35 Coil Pusher 16 Total Length Outer Diametre Distal Top Outer Diametre M M M M M M M M M Contour SE Microspheres / Embolisationssphären / Particules d'embolisation / Partículas de embolización Size (µm) Volume (ml) Syringues / Box M M M M M M M M M M

4 Contour PVA Embolisation Particles / PVA Embolisationspartikel / Particules d'embolisation / Partículas de embolización Vials Particle Size Range (µm) M M M M M M M M M M M M M Occlusion Balloons Standard Occlusion Balloon Catheters / Standard Okklusions-Ballonkatheter / Cathéters d'occlusion à ballonnet standard Catéteres de balón de oclusión estándar Catheter Size (F / mm) Lumens Usable Length (cm) Recommended Guidewire Inflated Balloon M M Berenstein Occlusion Balloon Catheters (Large Lumen)* / Okklusions-Ballonkatheter (großes Lumen)* Cathéters d'occlusion à ballonnet (grande lumière)* / Catéter de balón de oclusión tipo Berenstein (lumen grande)* Catheter Size (F / mm) Lumens Usable Length (cm) Recommended Guidewire Inflated Balloon M *Berenstein Occlusion Balloon Catheter is approved for use with microcatheters and embolics *Der Berentstein Okklusions Ballon ist Katheter zugelassen für die Nutzung mit Mikrokathertern und embolische Produkten *El catéter Balón de Oclusión Berentein es aprobado para su utilización con Microcatéteres y material embolizante *Le catheter ballon occlusif Berenstein est approuvé pour l utilisation avec des microcatheters et des agents d embolisation

5 FEB 11 20Hi Section 2 510(k) Summary (Pursuant To Section 12 the SAFE MEDICAL DEVICES ACT 1990) Submitter's Name and Address Contact Person Classification Name Boston Scientific Corporation One Scimed Place Maple Grove, MN Debbie Mclntire Senior Regulatory Affairs Specialist Boston Scientific Debbie.Mcliitire(J~bsci.coni Phone: (408) Fax: (763) Vascular enmholization device Product Code KRD 1) Fibered Platinum Coils Common or Usual Name 2) Fibered Platinum Coils Proprietary Name Names Predicate Devices 1 ) VortX- I8TM, VortXM Diamond -18, Straight- 18, Figure 8-18, Multi-Loop-i18, Complex Helical- IS Fibered Platinum Coil 2) VortXTM-35, 2D Helical-35 Fibered Platinum Coils 1) Target Therapeutics Peripheral Coils (K ) 2) Target Therapeutics Fibered Platinum Coils (K955293) Reasn SumisionModifications fr to the device labeling related to Reasn SumisionMRI fr compatibility.

6 Device 1 ) Boston Scientific's Fibered Platinum Coils consist platinum-tungsten alloy coils with synthetic fibers and are available in six different shapes; Vortx, Vortx Diamond, Complex Helical, Figure-8, Multi-Loop and Straight. The coil is provided with an introducer that is secured at both ends by a retaining clip during shipping and storage. The coil plunger, supplied with the coil, is used to push the coil out the introducer and into the microcatheter. 2) Boston Scientific VortX-35 and 2D Helical-35 Fibered Platinum Coils are helically-shaped platinum-tungstent alloy coils with synthetic fibers. The coils are provided with an introducer that is secured at both ends by a retaining clip during shipping and storage. A coili plunger, supplied with the coil, is used to push the coil out the introducer and into the catheter. Boston Scientific's and Fibered Intended Use Platinum Coils are intended for arterial and venous embolizations in the peripheral vasculature. Non-clinical testing demonstrates that the Vortx- 18, Vortx Diamond-iS, Straight-IS8, Figure 8-18, Multi-Loop-iS, Complex Helical-IS, Vortx-35 and 2D Helical-35 Fibered Platinum Coils will not present additional risk to a patient during a MMI procedure in comparison to risks imposed by gravitational, and other normal daily activities, or a temperature rise that is experienced during a feverish condition. The results testing Non-Clinical and Clinical Test conducted under methods described by ASTM Summary F , ASTM F e1, ASTM F and ASTM F have demonstrated that the Coils are MR Conditional and can be scanned safely under a static magnetic field 1.5 Tesla or 3.0 Tesla in normal operating mode,and in a static magnetic field gradient less than 25 T/m. Date prepared. September 2010 Testing at field strengths other than 1.5 Tesla or 3 Tesla has not been performed to evaluate coil migration or heating