DXT · Class II · 21 CFR 870.1650

FDA Product Code DXT: Injector And Syringe, Angiographic

Leading manufacturers include Medrad, Inc., Osprey Medical, Inc. and Coeur, Inc..

210
Total
210
Cleared
146d
Avg days
1978
Since
210 devices
145–168 of 210
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
Cleared Nov 14, 1983
DIGITAL INJECTOR SYS
K833138
Sybron Corp.
Cardiovascular · 61d
Cleared Dec 30, 1982
BACKSTOP VALVE W/SIDE ARM
K823190
Vertex Medical Corp.
Cardiovascular · 65d
Cleared Dec 30, 1982
DISPOSABLE PLASTIC STOPCOCK
K823191
Vertex Medical Corp.
Cardiovascular · 65d
Cleared Dec 30, 1982
TUOHY-BORST ADAPTER W/SIDE ARM
K823192
Vertex Medical Corp.
Cardiovascular · 65d
Cleared Dec 30, 1982
VERTEX MONITORING CATHETER
K823253
Vertex Medical Corp.
Cardiovascular · 59d
Cleared Dec 30, 1982
REUSABLE METAL STOPCOCK
K823254
Vertex Medical Corp.
Cardiovascular · 59d
Cleared Dec 30, 1982
ULTRA-ASEPT ANGIOGRAPHIC SYRINGE/SPARE
K823256
Vertex Medical Corp.
Cardiovascular · 59d
Cleared Dec 30, 1982
CLEAR VINYL MONITORING CONNECTOR
K823340
Vertex Medical Corp.
Cardiovascular · 52d
Cleared Sep 28, 1982
MARK V
K822536
Medrad, Inc.
Cardiovascular · 35d
Cleared Apr 29, 1980
QUICK FILL
K800823
Medrad, Inc.
Cardiovascular · 15d
Cleared Apr 08, 1980
ANGIOPLASTY INJECTOR
K800613
Medrad, Inc.
Cardiovascular · 21d
Cleared Dec 11, 1979
USCI BALLOON DILATATION INFLATION DEV.
K791782
C.R. Bard, Inc.
Cardiovascular · 90d
Cleared Dec 11, 1979
USCI PRESSURE GAUGE
K791793
C.R. Bard, Inc.
Cardiovascular · 88d
Cleared Aug 17, 1978
DISPOSABLE SYRINGE FILL TUBE
K781334
Mallinckrodt Group, Inc.
Cardiovascular · 15d