Medical Device Manufacturer · US , Walker , MI

Angiomedics, Inc. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1984

8

Total

8

Cleared

0

Denied

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

8 devices

1-8 of 8

Cleared Dec 15, 1987

SCHNEIDER-SHILEY ANGIOPORT(TM) PTCA INTRO W/HEMO

Cardiovascular · 123d

Cleared Sep 14, 1987

SCHNEIDER-SHILEY BIFLATOR BALLOON INFLATION DEVICE

Cardiovascular · 83d

Cleared Sep 14, 1987

SCHNEIDER-SHILEY SOFTRAC-PTA(TM) ANGIO. CATHETER

Cardiovascular · 77d

Cleared Mar 03, 1987

SOFTIP CORONARY SINUS CARDIOPLEGIA CATHETER

Cardiovascular · 187d

Cleared Jul 16, 1986

ANGIOMEDICS CATH SHEATH INTRODUC W/HEMOSTASIS VALV

Cardiovascular · 105d

Cleared Oct 11, 1985

ANGIOMEDICS SOFTIP CATHETER

Cardiovascular · 95d

Cleared Apr 03, 1985

ANGIOMEDIC'S CATHETER-DIAGNOSTIC INTRAVASCULAR

Cardiovascular · 70d

Cleared Feb 04, 1984

SOFTIP CATHETER

Cardiovascular · 58d