AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK2 MONORAIL, MAVERICK (OTW), QUANTUM MAVERICK (OTW) PTCA CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS SIMPSON-ROBERT CORONARY DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MERLIN PTCA CATHETER (OTW) AND NC MERLIN PTCA CATHETER (OTW)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MERLIN PTCA CATHETER (OTW) AND NC MERLIN PTCA CATHETER (OTW)

NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation Catheter; TREK™ RX Coronary Dilatation Catheter; TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ RX Coronary Dilatation Catheter; MINI TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ II OTW Coronary Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

REEF HP 0.035 OTW PTA BALLOON DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

.014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

STERLING OTW PTA BALLOON DILATATION CATHETER, MODEL H74939032-XXXXXX

FDA 510(k)

FDA Class 2 ·Cardiovascular

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SIMPSON-ROBERT PTCA CATHETER ACS RX LIFESTREAM AND ACS OTW LIFESTREAM PTCA CATHETERS WITH 30MM BALLOON LENGTH

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CUTTING BALLOON ULTRA 2

PERCUTANEOUS CV CATHETER INSERTION KIT W OR W/O CV

FDA 510(k)

FDA Class 2 ·General Hospital