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 |
|---|---|---|---|
| Jan 13, 2016 | K153125 | IntraNovo Microcatheter Texasmedical Technologies, Inc. | DQO |
| Dec 18, 2015 | K151126 | Foresight Intracardiac Echocardiography (ICE) System Colibri Technologies, Inc., CA | DQO |
| Oct 29, 2015 | K152605 | Impulse Angiographic Catheter, Expo Angiographic Catheter Boston Scientific Corporation | DQO |
| Oct 19, 2015 | K150232 | Radifocus Optitorque Angiographic Catheter Ashitaka Factory of Terumo Corp., JP | DQO |
| Oct 14, 2015 | K151724 | AngioDynamics Mariner Angiographic Catheters AngioDynamics, Inc. | DQO |
| Jun 26, 2015 | K143398 | Plato MICROCATH 27B Microcatheter Scientia Vascular, LLC | DQO |
| Jun 25, 2015 | K143604 | Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic Catheters Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S, TR | DQO |
| Apr 23, 2015 | K142817 | IntraNovo 25 Microcatheter Texasmedical Technologies, Inc. | DQO |
| Mar 20, 2015 | K140356 | SUMMED HIGH PRESSURE LINE Sunny Medical Device (Shenzhen) Co., Ltd. | DQO |
| Jan 12, 2015 | K143588 | Surefire Infusion System 021 Surefire Medical, Inc. | DQO |
| Jan 9, 2015 | K133130 | BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER Cook, Inc. | DQO |
| Sep 19, 2014 | K141453 | ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETER Lightlab Imaging, Inc. | DQO |
| Aug 18, 2014 | K141769 | OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER Lightlab Imaging, Inc. | DQO |
| Feb 26, 2014 | K131770 | PRESSURE CONNECTING TUBE Shenzhen Ant Hi-Tech Industrial Co., Ltd., CN | DQO |
| Oct 11, 2013 | K131437 | MODIFIED CONCENTRIC MICROCATHETER Concentric Medical, Inc. | DQO |
| Mar 4, 2013 | K123818 | URSA ANGIOGRAPHIC CATHETER Curative Medical Technology, Inc. | DQO |
| Dec 14, 2012 | K122937 | SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX) Cook, Inc. | DQO |
| Sep 14, 2012 | K121694 | IMAGER II ANGIOGRAPHIC CATHETER Boston Scientific Corp | DQO |
| Aug 17, 2012 | K120008 | MEDLINE HIGH PRESSURE INJECTION TUBING Medline Industries, Inc. | DQO |
| Aug 2, 2012 | K120917 | HEADWAY DUO MICROCATHETER MicroVention, Inc. | DQO |
| Jul 30, 2012 | K121734 | PLATO MICROCATH 27 MICROCATHETER Scientia Vascular, LLC | DQO |
| Jul 17, 2012 | K121954 | NMI MICROCATHETER Navilyst Medical, Inc. | DQO |
| Jul 16, 2012 | K113335 | HEARTRAIL III GUIDING CATHETER Terumo Corporation, JP | DQO |
| Jul 11, 2012 | K113819 | MONGOOSE ANGIOGRAPHIC CATHETER Pediacath, Inc. | DQO |
| Jun 14, 2012 | K121677 | SUREFIRE HI-FLOW MICROCATHETER Surefire Medical, Inc. | DQO |
| May 21, 2012 | K120495 | IMPULSE AND EXPO ANGIOGRAPHIC CATHETER Boston Scientific Corp | DQO |
| Mar 30, 2012 | K112452 | ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS AngioDynamics, Inc. | DQO |
| Mar 29, 2012 | K120893 | IMAGER II ANGIOGRAPHIC CATHETERS Boston Scientific Corp | DQO |
| Mar 9, 2012 | K113260 | MODIFIED CONCENTIRC MICROCATHETER Concentric Medical, Inc. | DQO |
| Feb 23, 2012 | K113737 | SUREFIRE GUIDE SHEATH Surefire Medical, Inc. | DQO |
| Jan 5, 2012 | K113638 | NMI 2.8 MICROCATHETER Navilyst Medical, Inc. | DQO |
| Sep 9, 2011 | K102633 | BIOTEQ ANGIOGRAPHIC CATHETER Bioteque Corp. | DQO |
| Aug 19, 2011 | K112124 | MICROCATHETER Navilyst Medical, Inc. | DQO |
| Jul 6, 2011 | K111619 | MODIFIED CONCENTRIC MICROCATHETER Concentric Medical, Inc. | DQO |
| Jul 1, 2011 | K110643 | MERIT MARQUIS FLOW SWITCH Merit Medical Systems, Inc., IE | DQO |
| Jun 24, 2011 | K110459 | SUREFIRE INFUSION CATHETER SYSTEM Surefire Medical, Inc. | DQO |
| Feb 11, 2011 | K110103 | EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER Edwards Lifesciences, LLC | DQO |
| Jul 19, 2010 | K101625 | COHEN CROSSOVER CATHETER Vascular Solutions, Inc. | DQO |
| Jul 1, 2010 | K101669 | THERMODILUTION CATHETER Biosensors Intl. Pte. , Ltd., SG | DQO |
| Jun 2, 2010 | K101239 | VIEWFLEX PLUS ICE CATHETER St Jude Medical | DQO |
| Feb 12, 2010 | K093004 | IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING Merit Medical Systems, Inc. | DQO |
| Jan 29, 2010 | K090427 | URSA ANGIOGRAPHIC CATHETER Curative Medical Technology, Inc. | DQO |
| Jan 13, 2010 | K092118 | ANGIOGRAPHIC CATHETER, MODEL ANGIOS Oscor, Inc. | DQO |
| Jan 5, 2010 | K083384 | THERMODILUTION CATHETER Biosensors Intl. Pte. , Ltd., SG | DQO |
| Nov 20, 2009 | K092702 | MICRUS MICROCATHETER, MODEL COURIER 270 Micrus Endovascular Corporation | DQO |
| Oct 16, 2009 | K091780 | GUIDED MEASUREMENT CATHETER (GMC) Mediguide, Ltd. | DQO |
| Sep 11, 2009 | K092372 | HEARTRAIL III GUIDING CATHETER Terumo Corp. | DQO |
| Jul 30, 2009 | K091961 | MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047 Concentric Medical, Inc. | DQO |
| May 6, 2009 | K083922 | MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-00 Micrus Endovascular Corporation | DQO |
| Feb 19, 2009 | K090276 | ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. | DQO |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.