ClearanceBrief
Panels › Cardiovascular › Product code DXT · Class 2

Injector And Syringe, Angiographic

Regulation 870.1650

7510(k)s in 12 months (211 all time)
8recalls in 12 months (70 all time)
58recalls that name a 510(k)
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Top companies in DXT

Decided510(k)Device and applicantCode
May 31, 2000K991103MODIFICATION TO ACIST CL 100H
Acist Medical Systems
DXT
May 31, 2000K984231ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B
Invasatec
DXT
Mar 28, 2000K000013ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000
Acist Medical Systems
DXT
Mar 23, 2000K9838263S INJECTOR-CT CONTRAST DELIVERY SYSTEM
Unimachs Corp.
DXT
Dec 7, 1999K993774ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH
Acist Medical Systems
DXT
Dec 6, 1999K984088OPTISTAR MR INJECTOR SYSTEM
Mallinckrodt Inc., Liebel-Flarsheim Business
DXT
Nov 26, 1999K993728MEDRAD ENVISION CT INJECTOR SYSTEM
Medrad, Inc.
DXT
Jul 21, 1999K991557MEDRAD VISTRON CT INJECTOR SYSTEM
Medrad, Inc.
DXT
Mar 11, 1999K984418UNIVERSAL ADJUSTABLE T-RAIL TABLE BRACKET
Medrad, Inc.
DXT
Oct 9, 1998K982814MEDRAD VISTRON CT INJECTOR SYSTEM
Medrad, Inc.
DXT
Apr 3, 1998K973334OZ POWER SYRINGE
Cardiovascular Innovations
DXT
Dec 5, 1997K963982ACIST ANGIOGRAPHIC INJECTOR
Invasatec
DXT
Nov 25, 1997K973230MONARCH (IN 2125)/INTELLISYSTEM (IN 1125)
Merit Medical Systems, Inc.
DXT
Oct 8, 1997K971712COEUR 130 ML ANGIOGRAPHIC SYRINGE
Coeur Laboratories, Inc.
DXT
Sep 23, 1997K963071ANGIOMAT ILLUMENA
Mallinckrodt Inc., Liebel-Flarsheim Business
DXT
Apr 29, 1997K964642MEDRAD DISPOSABLE SYRINGES
Medrad, Inc.
DXT
Mar 19, 1997K962141VOLUME CONTROL SYRINGE MODEL VCD-SYR-10
B.Braun Medical, Inc.
DXT
Oct 4, 1996K955685RNS STERILE, DISPOSABLE CT BIOPSY TRAY
Contour Fabricators of Florida, Inc.
DXT
Sep 19, 1996K960674CONTRAST INJECTION LINES
B.Braun Medical, Inc.
DXT
Sep 12, 1996K960965FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211
Coeur Laboratories, Inc.
DXT
Aug 6, 1996K960430CONTROL SYRINGE
Scientific Device Manufacturer, LLC
DXT
May 2, 1996K955684RNS STERILE, DISPOSABLE ANGIOGRAPHIC TRAY
Contour Fabricators of Florida, Inc.
DXT
Feb 21, 1996K955381B. BRAUM ANGIOGRAPHIC/ANGIOPLASTY KIT
B.Braun Medical, Inc.
DXT
Sep 25, 1995K935668MEDRAD SPECTRIS MR INJECTOR
Medrad, Inc.
DXT
Jul 21, 1995K951802SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT
Scimed Life Systems, Inc.
DXT
Jun 15, 1995K934086MEDRAD ENVISION CT INJECTOR AND QWIK FIT SYRINGE
Medrad, Inc.
DXT
Mar 17, 1995K942381LOW PRESSURE INJECTION TUBING, COILED LINE, EXTENSION TUBING
Apogee, Inc.
DXT
Jan 4, 1995K944875ANGIOMAT 3000, 6000, CT INJECTOR
Lievel-Flarsheim Co.
DXT
Dec 13, 1994K933846ANGIOGRAPHY SYRINGE KITS
Angiodynamics, Div. E-Z-Em, Inc.
DXT
Feb 25, 1994K933908MEDRAD CT CUSTOM CONVENIENCE KIT
Medrad, Inc.
DXT
Dec 16, 1993K932083XDCS-100
Microwave Medical Systems, Inc.
DXT
Feb 22, 1993K923117CAVERNOSOMETRY MODULE FOR MENUET
Dantec Medical, Inc.
DXT
Jan 21, 1993K924116MEDRAD MCT, MCT PLUS INJECTOR/MEDRAD FRONT LOAD
Medrad, Inc.
DXT
Jul 30, 1992K913624MEDRAD MCT-PLUS INJECTOR
Medrad, Inc.
DXT
Jul 24, 1992K920135MEDROYAL ANGIOGRAPHIC CONTROL SYRINGE
Medroyal, Inc.
DXT
Feb 4, 1992K912944CT 8000 DIGITAL INJECTION SYSTEM
Mallinckrodt Group, Inc.
DXT
Sep 23, 1991K910594TRAC-WRIGHT SYSTEM, MODEL TW2
Dow Corning Wright
DXT
Sep 16, 1991K905819MEDRAD VARIBLE INFUSION INJECTOR
Medrad, Inc.
DXT
Aug 15, 1991K911166DIAGNOSTIC ULTRASOUND/URO-GYN UD 511
Diagnostic Ultrasound Corp.
DXT
Jul 18, 1991K911549INJECTOR FILL TUBE
The R Group
DXT
May 29, 1991K910873BD ANGIOGRAPHIC SYRINGE W/A ROTATING TIP
Bd Becton Dickinson Vacutainer Systems Preanalytic
DXT
Jan 15, 1991K904994CLOSED SYSTEM FLUSH SET
Argon Medical Corp.
DXT
Dec 13, 1990K902377ANGEFLATOR(TM)
Angeion Corp.
DXT
Dec 3, 1990K904212HIGH-PRESSURE CONNECTOR TUBE
Mallinckrodt Medical
DXT
Dec 3, 1990K902475CARDIO-PAK ANGIOGRAPHY CUSTOM PACKS
Cardio-Pak
DXT
Oct 17, 1990K903494MAINTENACE FLOW - ACCESORY DEVICE FOR CAVROPUMP
Life-Tech Intl., Inc.
DXT
Oct 5, 1990K903495LIQUID DETECTOR
Life-Tech Intl., Inc.
DXT
Sep 26, 1990K903390MEDRAD MARK V-PLUS INJECTOR
Medrad, Inc.
DXT
Aug 8, 1990K902221MODIFIED ANGIOGRAPHIC INJECTOR AND SYRINGE
Mallinckrodt Group, Inc.
DXT
Jul 19, 1990K901382ISOFLO(TM) HIGH PRESSURE INJECTION LINES
Healthdyne Cardiovascular, Inc.
DXT

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