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
1-20 of 20
Cleared Mar 29, 1996
SELECTOR ANGIOGRAPHIC CATHETER (VARIOUS MODELS)
K960801 · DQO
Cardiovascular · 31d
Cleared Mar 04, 1996
HEMO-VALVE
K955554 · DTL
Cardiovascular · 90d
Cleared Feb 07, 1996
EPIC INTRODUCER SHEATH
K960310 · DYB
Cardiovascular · 16d
Cleared Mar 03, 1993
MORSE(R) ANGIOGRAPHIC CATHETERS
K922552 · DQO
Cardiovascular · 278d
Cleared Jun 10, 1992
MORSE HEMOSTATIC CATHETER INTRODUCER SET
K915078 · DYB
Cardiovascular · 215d
Cleared Sep 11, 1991
MORSE VASCULAR INTRODUCER SET
K912961 · DYB
Cardiovascular · 65d
Cleared Apr 22, 1991
THE PERCEPTOR(TM) STAND ALONE TRANSDUCER
K910764 · DRS
Cardiovascular · 81d
Cleared Jan 03, 1991
MORSE BALLOON INFLATION DEVICE
K904275 · MAV
Cardiovascular · 107d
Cleared Sep 27, 1990
GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCER
K903606 · LIT
Cardiovascular · 59d
Cleared Aug 23, 1990
MORSE DT MANIFOLD
K902472 · DRS
Cardiovascular · 80d
Cleared Jun 26, 1990
NAMIC PTCA Y-ADAPTOR
K900652 · DTL
Cardiovascular · 137d
Cleared Apr 19, 1989
LIPID STOPCOCK
K890580 · DTL
Cardiovascular · 72d
Cleared Jan 12, 1989
NAMIC DUAL BACKCHECK VALVE
K884408 · DTL
Cardiovascular · 85d
Cleared Feb 05, 1988
NAMIC ANGIOGRAPHIC SYRINGE
K873955 · DXT
Cardiovascular · 130d
Cleared May 07, 1987
NAMIC COURNAND STYLE INTRODUCER NEEDLE
K871377 · DRC
Cardiovascular · 30d
Cleared May 06, 1987
NAMIC SELDINGER INTRODUCER NEEDLE
K871378 · DRC
Cardiovascular · 29d
Cleared May 06, 1987
NAMIC ONE PART INTRODUCER NEEDLE
K871382 · DRC
Cardiovascular · 29d
Cleared Oct 18, 1984
HIGH PRESSURE, 1 & 3 WAY STERILE DISPOS
K842829 · DTL
Cardiovascular · 90d
Cleared Oct 18, 1984
NAMIC ADB ANGIOGRAPHIC DUMP BAG
K843726 · DQO
Cardiovascular · 24d
Cleared Dec 01, 1983
NAMIC CONTINUOUS FLUSH DEVICE
K833271 · DRS
Cardiovascular · 71d
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