GORE-TEX(R) VASCULAR GRAFTS, PROCESS CHANGE

FDA 510(k)

FDA Class 2 ·Cardiovascular

STERILMED INTERMITTENT COMPRESSION SYSTEM, GARMENT MODELS 400 SERIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

COAXIAL DILATOR SET

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRINITY II SINGLE CHAMBER DVT PUMP

FDA 510(k)

FDA Class 2 ·Cardiovascular

CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

NELLCOR SYMPHONY N-3000 PATIENT MONITOR W/SP02 & ECG/N-3200 DISPLAY/PRINTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CORRUGATED FLEXIBLE POLYETHYLENE

FDA 510(k)

MODEL 484-01 BIPOLAR COAXIAL PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

SARNS RETROGRADE CANNULA

FDA 510(k)

FDA Class 2 ·Cardiovascular

INTERSEPT 40 MICRON FILTER W/TUBING

FDA 510(k)

FDA Class 2 ·Cardiovascular

PASSPORT V MONITOR, MODEL 0998-00-6100

FDA 510(k)

FDA Class 2 ·Cardiovascular

BOWEN REUSEABLE/DISPOSABLE ELECTRODE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters

FDA 510(k)

FDA Class 2 ·Cardiovascular

CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPACELABS SERIES 1000

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLOSED SYSTEM FLUSH SET

FDA 510(k)

FDA Class 2 ·Cardiovascular

BRAIDED GUIDING INTRODUCER

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER

FDA 510(k)

FDA Class 2 ·Cardiovascular