Medical Device Manufacturer · US , Irvine , CA

Cardiovascular Dynamics, Inc. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 1994

Recent clearances: 22 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CAR, FOCUS-PV BALLOON DILATATION CATHETER

11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - Cardiovascular Dynamics, Inc. Cardiovascular ✕

8 devices

1-8 of 8

Cleared Jun 18, 1997

FOCUS-PV BALLOON DILATATION CATHETER

Cardiovascular · 58d

Cleared Mar 28, 1997

FOCUS PV BALLOON DILATATION CATHETER

Cardiovascular · 193d

Cleared Aug 17, 1995

CVD PERIFLOW(TM) (SMALL VESSEL) BALLOON DILATATION CATHETER

Cardiovascular · 269d

Cleared Jun 21, 1995

FOCUS BALLOON DILATATION CATHETER

Cardiovascular · 50d

Cleared May 10, 1995

CVD BULLET INFUSION CATYHETER

Cardiovascular · 43d

Cleared May 04, 1995

CVD BULLETT HI-FLO INFUSION CATHETER

Cardiovascular · 37d

Cleared Dec 20, 1994

FOCUS BALLOON DILATATION CATHETER

Cardiovascular · 126d

Cleared Dec 20, 1994

CVD SMALL VESSEL BALLOON DILATATION CATHETER

Cardiovascular · 43d