Medical Device Manufacturer · US , Walker , MI

North American Instrument Corp. - FDA 510(k) Cleared Devices

28 submissions · 28 cleared · Since 1983

28

Total

28

Cleared

0

Denied

FDA 510(k) Regulatory Record - North American Instrument Corp. Cardiovascular ✕

20 devices

1-12 of 20

Cleared Mar 29, 1996

SELECTOR ANGIOGRAPHIC CATHETER (VARIOUS MODELS)

Cardiovascular · 31d

Cleared Mar 04, 1996

Cardiovascular · 90d

Cleared Feb 07, 1996

EPIC INTRODUCER SHEATH

Cardiovascular · 16d

Cleared Mar 03, 1993

MORSE(R) ANGIOGRAPHIC CATHETERS

Cardiovascular · 278d

Cleared Jun 10, 1992

MORSE HEMOSTATIC CATHETER INTRODUCER SET

Cardiovascular · 215d

Cleared Sep 11, 1991

MORSE VASCULAR INTRODUCER SET

Cardiovascular · 65d

Cleared Apr 22, 1991

THE PERCEPTOR(TM) STAND ALONE TRANSDUCER

Cardiovascular · 81d

Cleared Jan 03, 1991

MORSE BALLOON INFLATION DEVICE

Cardiovascular · 107d

Cleared Sep 27, 1990

GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCER

Cardiovascular · 59d

Cleared Aug 23, 1990

MORSE DT MANIFOLD

Cardiovascular · 80d

Cleared Jun 26, 1990

NAMIC PTCA Y-ADAPTOR

Cardiovascular · 137d

Cleared Apr 19, 1989

Cardiovascular · 72d