DXT · Class II · 21 CFR 870.1650

FDA Product Code DXT: Injector And Syringe, Angiographic

Leading manufacturers include Medrad, Inc., Osprey Medical, Inc. and Acist Medical Systems, Inc..

210
Total
210
Cleared
146d
Avg days
1978
Since
210 devices
97–120 of 210
Cleared Oct 08, 1997
COEUR 130 ML ANGIOGRAPHIC SYRINGE
K971712
Coeur Laboratories, Inc.
Cardiovascular · 152d
Cleared Sep 23, 1997
ANGIOMAT ILLUMENA
K963071
Mallinckrodt Inc., Liebel-Flarsheim Business
Cardiovascular · 412d
Cleared Apr 29, 1997
MEDRAD DISPOSABLE SYRINGES
K964642
Medrad, Inc.
Cardiovascular · 161d
Cleared Mar 19, 1997
VOLUME CONTROL SYRINGE MODEL VCD-SYR-10
K962141
B.Braun Medical, Inc.
Cardiovascular · 289d
Cleared Oct 04, 1996
RNS STERILE, DISPOSABLE CT BIOPSY TRAY
K955685
Contour Fabricators of Florida, Inc.
Cardiovascular · 295d
Cleared Sep 19, 1996
CONTRAST INJECTION LINES
K960674
B.Braun Medical, Inc.
Cardiovascular · 212d
Cleared Sep 12, 1996
FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211
K960965
Coeur Laboratories, Inc.
Cardiovascular · 185d
Cleared Aug 06, 1996
CONTROL SYRINGE
K960430
Scientific Device Manufacturer, LLC
Cardiovascular · 188d
Cleared May 02, 1996
RNS STERILE, DISPOSABLE ANGIOGRAPHIC TRAY
K955684
Contour Fabricators of Florida, Inc.
Cardiovascular · 140d
Cleared Feb 21, 1996
B. BRAUM ANGIOGRAPHIC/ANGIOPLASTY KIT
K955381
B.Braun Medical, Inc.
Cardiovascular · 89d
Cleared Sep 25, 1995
MEDRAD SPECTRIS MR INJECTOR
K935668
Medrad, Inc.
Cardiovascular · 668d
Cleared Jul 21, 1995
SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT
K951802
Scimed Life Systems, Inc.
Cardiovascular · 93d
Cleared Jun 15, 1995
MEDRAD ENVISION CT INJECTOR AND QWIK FIT SYRINGE
K934086
Medrad, Inc.
Cardiovascular · 660d
Cleared Feb 25, 1994
MEDRAD CT CUSTOM CONVENIENCE KIT
K933908
Medrad, Inc.
Cardiovascular · 198d
Cleared Feb 22, 1993
CAVERNOSOMETRY MODULE FOR MENUET
K923117
Dantec Medical, Inc.
Gastroenterology & Urology · 241d
Cleared Jan 21, 1993
MEDRAD MCT, MCT PLUS INJECTOR/MEDRAD FRONT LOAD
K924116
Medrad, Inc.
Cardiovascular · 160d
Cleared Jul 30, 1992
MEDRAD MCT-PLUS INJECTOR
K913624
Medrad, Inc.
Cardiovascular · 352d
Cleared Feb 04, 1992
CT 8000 DIGITAL INJECTION SYSTEM
K912944
Mallinckrodt Group, Inc.
Cardiovascular · 214d
Cleared Sep 23, 1991
TRAC-WRIGHT SYSTEM, MODEL TW2
K910594
Dow Corning Wright
Cardiovascular · 223d
Cleared Sep 16, 1991
MEDRAD VARIBLE INFUSION INJECTOR
K905819
Medrad, Inc.
Radiology · 259d
Cleared May 29, 1991
BD ANGIOGRAPHIC SYRINGE W/A ROTATING TIP
K910873
Bd Becton Dickinson Vacutainer Systems Preanalytic
Cardiovascular · 89d
Cleared Jan 15, 1991
CLOSED SYSTEM FLUSH SET
K904994
Argon Medical Corp.
Cardiovascular · 69d
Cleared Dec 03, 1990
HIGH-PRESSURE CONNECTOR TUBE
K904212
Mallinckrodt Medical
Cardiovascular · 82d
Cleared Oct 17, 1990
MAINTENACE FLOW - ACCESORY DEVICE FOR CAVROPUMP
K903494
Life-Tech Intl., Inc.
Gastroenterology & Urology · 75d