DXT · Class II · 21 CFR 870.1650

FDA Product Code DXT: Injector And Syringe, Angiographic

Leading manufacturers include Medrad, Inc., Merit Medical Systems, Inc. and Bayer Medical Care, Inc..

210
Total
210
Cleared
146d
Avg days
1978
Since
210 devices
73–96 of 210
Cleared Sep 26, 1990
MEDRAD MARK V-PLUS INJECTOR
K903390
Medrad, Inc.
Cardiovascular · 61d
Cleared Jan 19, 1990
B-D ANGIOGRAPHIC CONTROL SYRINGE
K895318
Bd Becton Dickinson Vacutainer Systems Preanalytic
Cardiovascular · 143d
Cleared Jan 19, 1990
USCI PRESTO DISPOSABLE INFLATION DEVICE
K896415
C.R. Bard, Inc.
Cardiovascular · 72d
Cleared May 19, 1989
HIGH PRESSURE CONNECTING SETS
K890208
E-Z-Em, Inc.
Cardiovascular · 122d
Cleared Apr 18, 1989
MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)
K884913
Merit Medical Systems, Inc.
Cardiovascular · 141d
Cleared Oct 14, 1988
ACS INDEFLATOR P/T 20
K883452
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 63d
Cleared Apr 28, 1988
MEDRAD MICROPROCESSOR CT INJECTION SYSTEM
K880493
Medrad, Inc.
Cardiovascular · 83d
Cleared Apr 22, 1988
ANGIO DRAPE PACK ACP-010FM
K880310
Arrow Intl., Inc.
Cardiovascular · 88d
Cleared Feb 11, 1988
DISPOSABLE CORONARY CONTROL SYRINGE 12CC
K875196
Merit Medical Systems, Inc.
Cardiovascular · 56d
Cleared Feb 05, 1988
MEDRAD MRI INJECTION SYSTEM
K873173
Medrad, Inc.
Cardiovascular · 177d
Cleared Oct 20, 1987
ACS INDEFLATOR PLUS (MODIFICATION #2)
K872981
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 81d
Cleared Aug 28, 1987
CAVROPUMP
K871129
Life-Tech Intl., Inc.
Gastroenterology & Urology · 161d
Cleared Nov 20, 1986
CHIN-FOGARTY INFLATION DEVICE
K863596
American Edwards Laboratories
Cardiovascular · 66d
Cleared Oct 31, 1986
CORDIS REUSABLE INFLATION DEVICE FOR ANGIOPLASTY
K863537
Cordis Corp.
Cardiovascular · 50d
Cleared Sep 23, 1986
USCI (R) DISPOSABLE INFLATION DEVICE
K863037
C.R. Bard, Inc.
Cardiovascular · 42d
Cleared Sep 03, 1986
MECHANICAL INFLATION DEVICE
K862547
American Edwards Laboratories
Cardiovascular · 62d
Cleared Apr 23, 1986
ANGIOJECT
K860842
Target Therapeutics
Cardiovascular · 50d
Cleared Feb 18, 1986
ROENTGENOGRAPHY SET & PRESSURE MONITORING LINE
K850861
Medical Components, Inc.
Cardiovascular · 354d
Cleared Dec 04, 1985
ACS INDEFLATOR (MODIFICATION)
K854310
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 41d
Cleared Jun 10, 1985
LEVEEN INFLATOR DISPOSABLE INFLATION SYRINGE
K851402
Medi-Tech, Inc.
Cardiovascular · 62d
Cleared Nov 13, 1984
ADVANCED CARDIOVASCULAR SYSTEMS ANGIOJECT
K844045
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 27d
Cleared Apr 17, 1984
CONTRAST MEDIA INJECT. SET CMS
K833645
Gish Biomedical, Inc.
Cardiovascular · 183d
Cleared Apr 17, 1984
ANGIOGRAPHIC DRAPE PACKS
K840281
Medrad, Inc.
Cardiovascular · 85d
Cleared Jan 13, 1984
ANGIOPLASTY INFLATION DEVICE & CARTR
K834107
Cordis Corp.
Cardiovascular · 45d