Panels › Cardiovascular › Product code DQO · Class 2
Catheter, Intravascular, Diagnostic
Regulation 870.1200
3510(k)s in 12 months (501 all time)
26recalls in 12 months (285 all time)
246recalls that name a 510(k)
Top companies in DQO
| Company | 510(k)s | Recalls |
|---|---|---|
| Cook Incorporated | 15 | 85 |
| Boston Scientific Corp | 20 | 73 |
| Merit Medical Systems, Inc. | 8 | 33 |
| Cordis Corp. | 29 | 8 |
| AngioDynamics, Inc. | 11 | 23 |
| Vascular Solutions, Inc. | 12 | 10 |
| C.R. Bard, Inc. | 16 | 0 |
| Scimed Life Systems, Inc. | 16 | 0 |
| LeMaitre Vascular, Inc. | 0 | 12 |
| Target Therapeutics | 10 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 6, 2009 | K090040 | RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP) Terumo Medical Corp. | DQO |
| Jan 28, 2009 | K081846 | GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951 Vascular Solutions, Inc. | DQO |
| Sep 24, 2008 | K082736 | RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER Terumo Medical Corp. | DQO |
| Apr 17, 2008 | K073585 | INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900, 7901, 7902, 7903, 7904 AND 7905 Vascular Solutions, Inc. | DQO |
| Feb 1, 2008 | K073200 | GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582 Vascular Solutions, Inc. | DQO |
| Dec 18, 2007 | K072796 | MEERCI RETRIEVER, CONCENTRIC MICROCATHETER, MODELS 90050, 90060, 90065, 90066, 90070,90092, 90043, 90044 Concentric Medical, Inc. | DQO |
| Oct 5, 2007 | K072526 | MICRUS COURIER ENZO MICROCATHETER 0.0190 Micrus Endovascular Corporation | DQO |
| Sep 6, 2007 | K071196 | DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS Coeur, Inc. | DQO |
| May 24, 2007 | K070456 | MICRUS COURIER ENZO MICROCATHETER 0.017 Micrus Endovascular Corporation | DQO |
| Apr 16, 2007 | K063784 | DYE MANAGEMENT SYSTEM Icu Medical, Inc. | DQO |
| Mar 20, 2007 | K070011 | IBI INQUIRY CLEARICE INTRACARDIAC ECHOCARDIOGRAPHY ULTRASOUND IMAGING CATHETER Irvine Biomedical,Inc.(Ibi) | DQO |
| Jan 18, 2007 | K062877 | TWIN-PASS .023 DUAL ACCESS CATHETER, MODEL 5230 Vascular Solutions, Inc. | DQO |
| Jan 5, 2007 | K062627 | INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900 THROUGH 7905 Vascular Solutions, Inc. | DQO |
| Nov 30, 2006 | K063312 | MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942 Boston Scientific Corp | DQO |
| Aug 24, 2006 | K061733 | ANGIODYNAMICS SOFT-VU AND MARINER HYDROPHILIC COATED ANGIOGRAPHIC CATHETER AngioDynamics, Inc. | DQO |
| Aug 9, 2006 | K062126 | EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135 Biosphere Medical, Inc. | DQO |
| Aug 4, 2006 | K061963 | MICRUS MICROCATHETER COURIER PRE-SHAPED, MODELS MPS170045-00, MPS170090-00, MPS190045-00, MPS190090-00 Micrus Endovascular Corporation | DQO |
| Aug 4, 2006 | K060010 | NAUTIFLUX Sedat | DQO |
| Aug 2, 2006 | K061565 | LANGSTON DUAL LUMEN CATHETER Vascular Solutions, Inc. | DQO |
| Jun 23, 2006 | K052908 | INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5 Infraredx, Inc. | DQO |
| May 12, 2006 | K060116 | MICRUS COURIER MICROCATHETERS Micrus Endovascular Corporation | DQO |
| Mar 24, 2006 | K060175 | ISIGHT IMAGING CATHETER, MODEL 38986 Boston Scientific Corp | DQO |
| Mar 8, 2006 | K052637 | THEROX INFUSION CATHETER, MODEL INCA-1 Therox, Inc. | DQO |
| Jan 19, 2006 | K053171 | MERIT IMPRESS DIAGNOSTIC CATHETER Merit Medical Systems, Inc. | DQO |
| Dec 22, 2005 | K052865 | HOSPIRA CATH LAB CONVENIENCE KITS Icu Medical, Inc. | DQO |
| Nov 2, 2005 | K051561 | ASAHI ANGIOGRAPHIC CATHETER Asahi Intecc Co., Ltd. | DQO |
| Sep 2, 2005 | K050863 | IMAGER II ANGIOGRAPHIC CATHETER Boston Scientific Corp | DQO |
| Jun 24, 2005 | K051395 | LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER Vascular Solutions, Inc. | DQO |
| Jun 7, 2005 | K050371 | MEDRAD VANGUARD DX ANGIOGRAPHIC CATHETER Medrad, Inc. | DQO |
| May 20, 2005 | K050684 | ATLANTIS PV Boston Scientific Corp | DQO |
| May 18, 2005 | K050168 | LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER Vascular Solutions, Inc. | DQO |
| Mar 30, 2005 | K050577 | ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014 Boston Scientific Corp | DQO |
| Nov 18, 2004 | K042685 | METRICATH SYSTEM Angiometrx, Inc., CA | DQO |
| Sep 23, 2004 | K041909 | VASCULAR SOLUTIONS LANGSTON DUAL LUMEN PIGTAIL CATHETER (DLP) Vascular Solutions, Inc. | DQO |
| Aug 26, 2004 | K041123 | RINSPIRATION SYSTEM,RINSPIRATION SYSTEM SHORT TIP, MODELS FG01477/FG01703 Kerberos Proximal Solutions, Inc. | DQO |
| Jun 30, 2004 | K034043 | H-FLOW VALVE Elcam Medical Acal, IL | DQO |
| Jun 18, 2004 | K040830 | PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS NuMED, Inc. | DQO |
| May 21, 2004 | K041291 | RINSPIRATION SYSTEM Kerberos Proximal Solutions, Inc. | DQO |
| Apr 29, 2004 | K040776 | ATLANTIS SR, MODEL C4020; ATLANTIS SR PLUS, MODEL 35975 Boston Scientific Corp | DQO |
| Feb 24, 2004 | K032888 | CREATION NM DIAGNOSTIC CATHETERS Neich Medical (Shenzhen) Company Limited, CN | DQO |
| Dec 12, 2003 | K033583 | PROGREAT Terumo Medical Corp. | DQO |
| Dec 9, 2003 | K031599 | CD LEYCOM PRESSURE/VOLUME CATHETERS Cd Leycom BV, NL | DQO |
| Sep 25, 2003 | K031485 | RINSPIRATION SYSTEM Kerberos Proximal Solutions | DQO |
| Sep 10, 2003 | K032624 | MICRUS MICROCATHETER Micrus Corp. | DQO |
| Aug 26, 2003 | K032376 | ANGIODYNAMICS ACCU-VU SIZING ANGIOGRAPHIC CATHETER AngioDynamics, Inc. | DQO |
| Jun 26, 2003 | K024000 | METRICATH SYSTEM COMPRISED OF METRICATH 1000 CONSOLE & METRICATH BALLOON CATHETER Angiometrx, Inc. | DQO |
| Jun 18, 2003 | K023591 | ULTRA HIGH PRESSURE INJECTOR LINES Deroyal Industries, Inc. | DQO |
| Mar 12, 2003 | K022004 | CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1 Biosensors International-USA | DQO |
| Jan 14, 2003 | K024126 | CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT Abbott Laboratories | DQO |
| Nov 26, 2002 | K023681 | RENEGADE STC 18 MICROCATHETER Boston Scientific Corp | DQO |
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