MAV · Class II · 21 CFR 870.1650

FDA Product Code MAV: Syringe, Balloon Inflation

Leading manufacturers include Merit Medical Systems, Inc., Boston Scientific Corp and Advanced Cardiovascular Systems, Inc..

57
Total
57
Cleared
120d
Avg days
1981
Since
57 devices
25–48 of 57
Cleared Aug 31, 1995
OSCILFLATOR
K952566
Surgical Technologies, Inc.
Cardiovascular · 90d
Cleared Feb 10, 1995
MONARCH AP(TM)
K943597
Merit Medical Systems, Inc.
Cardiovascular · 202d
Cleared Oct 18, 1994
MEDTRONIC EVEREST INFLATION DEVICE
K942269
Medtronics Interventional Vascular
Cardiovascular · 161d
Cleared Aug 11, 1994
MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICE
K940896
Medex, Inc.
Cardiovascular · 168d
Cleared Aug 01, 1994
IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING
K940425
Imagyn Medical, Inc.
Cardiovascular · 182d
Cleared Dec 08, 1992
10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE
K922573
Boston Scientific Corp
Cardiovascular · 190d
Cleared Aug 07, 1992
ACS ANGIOTRAK(TM) SYSTEM
K921719
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 120d
Cleared Feb 04, 1992
MONARCH(TM) INFLATION SYRINGE
K913994
Merit Medical Systems, Inc.
Cardiovascular · 151d
Cleared Sep 16, 1991
CORDIS INFLATOR DEVICE
K912644
Cordis Corp.
Cardiovascular · 91d
Cleared Jul 12, 1991
MEDFLATOR INFLATION SYSTEM
K910958
Medex, Inc.
Cardiovascular · 128d
Cleared Jun 24, 1991
BIPOLAR FORCEPS
K912544
Everest Medical Corp.
Cardiovascular · 14d
Cleared Apr 02, 1991
CONDOR ANALOG INFLATION SYRINGE
K904508
Professional Medical Services
Cardiovascular · 180d
Cleared Jan 16, 1991
CONDOR DIGITAL INFLATION SYRINGE
K904954
Professional Medical Services
Cardiovascular · 72d
Cleared Jan 03, 1991
MORSE BALLOON INFLATION DEVICE
K904275
North American Instrument Corp.
Cardiovascular · 107d
Cleared Dec 03, 1990
DISPOSABLE INFLATION GAUGE
K902695
Cook Urological, Inc.
Cardiovascular · 167d
Cleared Dec 03, 1990
INFLATION/DEFLATION DEVICE
K904394
Boston Scientific Corp
Cardiovascular · 69d
Cleared Feb 28, 1990
CATHETER BALLOON DILATOR PRESSURE GAUGE
K895511
Argon Medical Corp.
Cardiovascular · 169d
Cleared Feb 28, 1990
ACS INDEFLATOR XX
K896849
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 85d
Cleared Dec 20, 1989
INFLATION PRO II
K895836
Baxter Healthcare Corp
Cardiovascular · 78d
Cleared Jun 09, 1986
SCHNEIDER-SHILEY INFLATION SYRINGES
K861607
Shiley, Inc.
Cardiovascular · 41d
Cleared Oct 23, 1984
SCIMED PM200 INFLATION MANOMETER
K843448
Scimed Life Systems, Inc.
Cardiovascular · 48d
Cleared Aug 11, 1983
EDSLAB PRESSURE GAUGE
K832323
American Edwards Laboratories
Cardiovascular · 27d