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)
Top companies in DXT
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 14, 2009 | Merit 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 |
DXT | K884913 |
| Aug 30, 2009 | Acist 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 |
DXT | K040298 |
| Jun 1, 2009 | Medrad Inc MEDRAD Sterile Disposable Syringe Kit, catalog number DSK 130-Q, Angiographic Syringe for delivery of contrast media. Terminated |
DXT | None listed |
| Jan 8, 2009 | Acist 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 |
DXT | K010390 K991103 |
| Sep 23, 2008 | Acist 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 |
DXT | K040298 |
| Sep 3, 2008 | Mallinckrodt Inc Covidien/ Mallinckrodt CT9000, CT9000 ADV (J-Bow component 241300), contrast media delivery system for diagnostic imaging. Terminated |
DXT | K031339 K912944 |
| Dec 11, 2007 | Medrad 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 |
DXT | None listed |
| Dec 8, 2007 | Acist 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 |
DXT | K984231 |
| Oct 13, 2007 | Mallinckrodt Inc Angiomat Illumena Injector with Auxiliary Console, Mallinckrodt, Inc., Hazelwood, MO. Terminated |
DXT | K963071 |
| Oct 4, 2007 | Lemaitre Vascular, Inc. CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC) Terminated |
DXT | K973334 |
| Nov 16, 2005 | Medrad Inc Stellant CT Injection System. Powered Injector with Syringe. Angiographic Injector and Syringe. Model numbers S, SX, D, and DX Terminated |
DXT | K023183 K033881 |
| Nov 24, 2004 | Medrad Inc Stellant Dual Syringe Kits. CT Injector and Accessories. Catalog Number SDS-CTP-QFT and SDS-CTP-SPK. Terminated |
DXT | K023183 |
| Oct 28, 2004 | Merit Medical Systems, Inc 8 ml Inject8 Coronary Control Syringe, sterile. Terminated |
DXT | K875196 |
| Oct 22, 2004 | Medrad Inc Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT Terminated |
DXT | K023183 |
| Jul 20, 2004 | Acist Medical Systems AngioTouch Kit Model H1000P Hand Controller kits used with the ACIST Contrast Management System. Terminated |
DXT | K984231 K991103 |
| Jul 20, 2004 | Kyphon 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 |
DXT | None listed |
| Jul 20, 2004 | Kyphon 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 |
DXT | K011811 |
| Nov 19, 2003 | Merit 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 |
DXT | K884913 |
| Nov 19, 2003 | Merit 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 |
DXT | K011811 |
| Oct 24, 2003 | Acist Medical Systems ACIST Automated Manifold (Transducer) Kit, Model BT2000, SKU #014613 (used with ACIST Contrast Management Systems (CMS2000) and E2000 Voyager Units) Terminated |
DXT | K984231 K991103 |
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