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..

58
Total
58
Cleared
123d
Avg days
1981
Since
58 devices
49–58 of 58
Cleared Oct 09, 1990
SCIMED ENCORE INFLATION DEVICE, MODEL SM2500
K903503
Scimed
Cardiovascular · 67d
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 Feb 26, 1990
SMALL CATHETER INFLATOR
K896005
Allied Systems Co.
Cardiovascular · 136d
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 Dec 03, 1985
MODEL 1100 APC(ANGIOPLASTY PRESSURE CONTROLLER)
K853136
E.A. Fischione Instrument Mfg.
Cardiovascular · 130d
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
Cleared Oct 13, 1981
DORROS-SPRING PRESSURIZER
K812304
Cardiovascular Diagnostic Services
Cardiovascular · 56d