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Establishment Registration & Device Listing

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Product Code : OAD

Establishment
Name

Registration Number

Current
Registration Yr

Boston Scientific Corporation

CA/USA

3001236349

2013

catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - Blazer II XP Temperature Ablation Catheter; Blazer Prime XP Temperature AblationCatheter; EPT 1000TC Cardiac Ablation Controller with Temperature Control; Maestro 3000 Cardiac Ablation System

Specification Developer

catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - Blazer Open Irrigated Ablation Catheter

U.S. Manufacturer of Export Only Devices

BOSTON SCIENTIFIC CORPORATION

COSTA RICA

3004859241

2013

catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - Blazer II XP Temperature Ablation Catheter; Blazer Prime XP Temperature AblationCatheter; EPT 1000TC Cardiac Ablation Controller with Temperature Control; Maestro 3000 Cardiac Ablation System

Manufacturer

HEI INC., ADVANCED MEDICAL DIVISION

CO/USA

1721752

2013

catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - Cool Point

Contract Manufacturer

catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - CoolFlow

Contract Manufacturer

IRVINE BIOMEDICAL, INC.

CA/USA

2030404

2013

catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - IBI-1500T6; Safire TX; Therapy; Therapy Dual 8

Manufacturer

catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - IBI-1500T9; Therapy Cool Path

Manufacturer

catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - IBI 1500T9-CP V1.6 Cardiac Ablation Generator; Safire BLU Duo Ablation Catheter; Therapy Cool Path Duo Ablation Catheter

Manufacturer

STOCKERT GMBH

GERMANY

9612355

2013

catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - Stockert-70

Manufacturer

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