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

DateFirm and productCodeLinked 510(k)
Dec 14, 2009Merit Medical Systems, Inc.
Merit Medical Systems, Inc. Monarch Inflation Syringe label reading in part: MONARCH CATALOG NUMBER IN2130 for inflation and deflation of interventional devices
Terminated
DXTK884913
Aug 30, 2009Acist Medical Systems
ACIST Automated Manifold Kit , REF Model BT2000, SKU # 014613, Sterile R, Made in Mexico, Manufacturer; ACIST LMedical Systems Inc, 7605 Fuller Road, Eden Prairie, MN .55344. The automated manifold ki
Terminated
DXTK040298
Jun 1, 2009Medrad Inc
MEDRAD Sterile Disposable Syringe Kit, catalog number DSK 130-Q, Angiographic Syringe for delivery of contrast media.
Terminated
DXTNone listed
Jan 8, 2009Acist Medical Systems
ACIST CVi Angiographic Injection System with Interface Cable for Toshiba Infinix-i cardiovascular X-ray system, Part Number 700318-002. The ACIST injection system is an angiographic injection system
Terminated
DXTK010390
K991103
Sep 23, 2008Acist Medical Systems
ACIST" BRACCO, AT P54 AngioTouch Kit , SKU # 014644, Sterile EO Manufacturer; ACTB Medical Systems, Inc. 7905 Fuller Road, Eden Prairie, MN 55344, Made in Mexico. Catalogue No: 800608-013 Intended t
Terminated
DXTK040298
Sep 3, 2008Mallinckrodt Inc
Covidien/ Mallinckrodt CT9000, CT9000 ADV (J-Bow component 241300), contrast media delivery system for diagnostic imaging.
Terminated
DXTK031339
K912944
Dec 11, 2007Medrad Inc
Medrad Avanta Multi-Patient Disposable Hand Controller, Angiographic Injector and Syringe. Catalog number AVA 500 HC, For Use with MEDRAD Avant Fluid Management System, MEDRAD, Inc., Indianola, PA 150
Terminated
DXTNone listed
Dec 8, 2007Acist Medical Systems
ACIST Multi-Use Syringe Kit, Model A2000; SKU # : 014612; labeled as STERILE; Manufactured: Acist Medical Systems, Inc., 7450 Flying Cloud Drive, Suite 150, Eden Prairie, MN 55344, USA. Catalogue No:
Terminated
DXTK984231
Oct 13, 2007Mallinckrodt Inc
Angiomat Illumena Injector with Auxiliary Console, Mallinckrodt, Inc., Hazelwood, MO.
Terminated
DXTK963071
Oct 4, 2007Lemaitre Vascular, Inc.
CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
Terminated
DXTK973334
Nov 16, 2005Medrad Inc
Stellant CT Injection System. Powered Injector with Syringe. Angiographic Injector and Syringe. Model numbers S, SX, D, and DX
Terminated
DXTK023183
K033881
Nov 24, 2004Medrad Inc
Stellant Dual Syringe Kits. CT Injector and Accessories. Catalog Number SDS-CTP-QFT and SDS-CTP-SPK.
Terminated
DXTK023183
Oct 28, 2004Merit Medical Systems, Inc
8 ml Inject8 Coronary Control Syringe, sterile.
Terminated
DXTK875196
Oct 22, 2004Medrad Inc
Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT
Terminated
DXTK023183
Jul 20, 2004Acist Medical Systems
AngioTouch Kit Model H1000P Hand Controller kits used with the ACIST Contrast Management System.
Terminated
DXTK984231
K991103
Jul 20, 2004Kyphon Inc
KyphXR brand KyphoPak Tray, a Introducer Tool kit for Inflation Syringe Kyphon Catalog Number: KPT1001, KPT1002, KPT1003, KPT1501, KPT1503, KPT2002, KPT2003 The medical device is distributed by Kyph
Terminated
DXTNone listed
Jul 20, 2004Kyphon Inc
KyphX Xpander brand Inflation Syringe; Merit Medical Part Number: K05-01290A. Kyphon Catalog Number: A08A. The medical device is distributed by Kyphon under the brand name KyphX Xpander Inflation S
Terminated
DXTK011811
Nov 19, 2003Merit Medical Systems, Inc
IntelliSystem25 Inflation Device and Fluid Dispensing Syringe - Label on package reads in part: ''INTELLISYSTEM 25 WITH MAP152 MAP152 CONTAINS: MERIT ACCESS PLUS LARGE BORE HEMOSTASIS VALVE, TORGUE DE
Terminated
DXTK884913
Nov 19, 2003Merit Medical Systems, Inc
Monarch Inflation Device and Fluid Dispensing Syringe - Latex Free MERIT MEDICAL. Sterile if package is unopened or undamaged. Part # IN2125/B .
Terminated
DXTK011811
Oct 24, 2003Acist Medical Systems
ACIST Automated Manifold (Transducer) Kit, Model BT2000, SKU #014613 (used with ACIST Contrast Management Systems (CMS2000) and E2000 Voyager Units)
Terminated
DXTK984231
K991103

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