Medical Device Manufacturer · US , Maple Grove , MN

Scimed - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1990

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Scimed Cardiovascular ✕

8 devices

1-8 of 8

Cleared Jul 21, 1999

SCIMED ANGIOGRAPHIC CATHETERS

Cardiovascular · 27d

Cleared Nov 13, 1995

SCIMED 6 FRENCH MICRO-MAX GUIDE CATHETER

Cardiovascular · 84d

Cleared Jul 01, 1993

SCIMED TRANSPORT STEERABLE GUIDE WIRE AND ACCESS.

Cardiovascular · 92d

Cleared Dec 10, 1992

SCIMED SIDELINER

Cardiovascular · 188d

Cleared Aug 17, 1992

SCIMED VIPER CATHETER

Cardiovascular · 265d

Cleared May 29, 1991

7FR. AND 8FR. TRIGUIDE GUIDING CATHETER ADD. CURVE

Cardiovascular · 83d

Cleared Dec 06, 1990

SCIMED CARDIOTHERM CARDIOPLEGIA DELIVERY SYSTEM

Cardiovascular · 86d

Cleared Oct 09, 1990

SCIMED ENCORE INFLATION DEVICE, MODEL SM2500

Cardiovascular · 67d