Establishment Registration & Device Listing

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Product Code : MCW

Establishment
Name

Registration Number

Current
Registration Yr

BOSTON SCIENTIFIC CORPORATION

MN/USA

2134265

2013

catheter, peripheral, atherectomy - Extra Support Guidewire and Guidewire Manipulation Device; Floppy Guidewire and Guidewire Manipulation Device; Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device; Rotablator Dynaglide Foot Pedal; Rotablator Rotational Atherectomy System; RotaLink Advancer Catheter Advancing Device; RotaLink Burr Exchangeable Burr Catheter; RotaLink Plus; RotaWire and wireClip Torquer

Specification Developer

catheter, peripheral, atherectomy - Guidewire and Guidewire Manipulation Device; Peripheral RotaLink Plus; Peripheral RotaWire Guidewire and wireClip Torquer; Pre-Connected Exchange Burr Catheter and Burr Advancing Device; Rotablator; Rotational Atherectomy System; Rotational Atherectomy System Console with Dynaglide Foot Pedal

Specification Developer

Boston Scientific Corporation

CA/USA

2939204

2013

catheter, peripheral, atherectomy - Extra Support Guidewire and Guidewire Manipulation Device; Floppy Guidewire and Guidewire Manipulation Device; Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device; Rotablator Dynaglide Foot Pedal; Rotablator Rotational Atherectomy System; RotaLink Advancer Catheter Advancing Device; RotaLink Burr Exchangeable Burr Catheter; RotaLink Plus; RotaWire and wireClip Torquer

Manufacturer

catheter, peripheral, atherectomy - Guidewire and Guidewire Manipulation Device; Peripheral RotaLink Plus; Peripheral RotaWire Guidewire and wireClip Torquer; Pre-Connected Exchange Burr Catheter and Burr Advancing Device; Rotablator; Rotational Atherectomy System; Rotational Atherectomy System Console with Dynaglide Foot Pedal

Manufacturer

BOSTON SCIENTIFIC CORPORATION

COSTA RICA

3004859241

2013

catheter, peripheral, atherectomy - Extra Support Guidewire and Guidewire Manipulation Device; Floppy Guidewire and Guidewire Manipulation Device; Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device; Rotablator Dynaglide Foot Pedal; Rotablator Rotational Atherectomy System; RotaLink Advancer Catheter Advancing Device; RotaLink Burr Exchangeable Burr Catheter; RotaLink Plus; RotaWire and wireClip Torquer

Manufacturer

catheter, peripheral, atherectomy - Guidewire and Guidewire Manipulation Device; Peripheral RotaLink Plus; Peripheral RotaWire Guidewire and wireClip Torquer; Pre-Connected Exchange Burr Catheter and Burr Advancing Device; Rotablator; Rotational Atherectomy System; Rotational Atherectomy System Console with Dynaglide Foot Pedal

Manufacturer

CARDIOVASCULAR SYSTEMS INCORPORATED

TX/USA

3008814558

2013

catheter, peripheral, atherectomy - DIAMONDBACK 360; ORBITAL ATHERECTOMY SYSTEM

Manufacturer

CARDIOVASCULAR SYSTEMS INCORPORATED

MN/USA

3004742232

2013

catheter, peripheral, atherectomy - DIAMONDBACK 360; ORBITAL ATHERECTOMY SYSTEM

Manufacturer

catheter, peripheral, atherectomy - Stealth 360 PAD System

Manufacturer

catheter, peripheral, atherectomy - ViperSlide Lubricant

Specification Developer

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Establishment Registration & Device Listing

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