Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK MONORAIL

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK OTW, MAVERICK MONORAIL & MAVERICK2 MONORAIL PTCA CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·QUANTUM MAVERICK MONORAIL AND OVER-THE-WIRE PTCA CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK MONORAIL PTCA CATHETER SYSTEM AND MAVERICK2 MONORAIL PTCA CATHETER SYSTEM

Catheter, Peritoneal, Long-Term Indwelling, Exempt

FDA classification

FDA Class 2 ·Catheter, Peritoneal, Long-Term Indwelling, Exempt

Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling

FDA classification

FDA Class 2 ·Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling

Catheter, Hemodialysis, Implanted, Coated

FDA classification

FDA Class 2 ·Catheter, Hemodialysis, Implanted, Coated

Catheter, Hemodialysis, Triple Lumen, Implanted

FDA classification

FDA Class 2 ·Catheter, Hemodialysis, Triple Lumen, Implanted

Tracking, Soft Tissue, Intraoperative

FDA classification

FDA Class 2 ·Tracking, Soft Tissue, Intraoperative

Subcutaneous Implanted Apheresis Port

FDA classification

FDA Class 2 ·Subcutaneous Implanted Apheresis Port

Oxygenator, Long Term Support Greater Than 6 Hours

FDA classification

FDA Class 2 ·Oxygenator, Long Term Support Greater Than 6 Hours

Tubing, Long Term Support Greater Than 6 Hours

FDA classification

FDA Class 2 ·Tubing, Long Term Support Greater Than 6 Hours

Blood Pump For Ecmo, Long-Term (> 6 Hours) Use

FDA classification

FDA Class 2 ·Blood Pump For Ecmo, Long-Term (> 6 Hours) Use

Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

FDA classification

FDA Class 2 ·Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Dual Lumen Ecmo Cannula

FDA classification

FDA Class 2 ·Dual Lumen Ecmo Cannula

Plate, Bone, Growth Control, Pediatric, Epiphysiodesis

FDA classification

FDA Class 2 ·Plate, Bone, Growth Control, Pediatric, Epiphysiodesis

Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position

FDA classification

FDA Class 2 ·Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position

Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System

FDA classification

FDA Class 2 ·Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System

Tunneled Catheter Remover

FDA classification

FDA Class 2 ·Tunneled Catheter Remover