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 |
|---|---|---|---|
| Jul 2, 1986 | K860867 | DIGITAL SUBTRACTION ANGIOGRAPHY CATHETERS AND SETS Medical Components, Inc. | DQO |
| Jun 27, 1986 | K862006 | STAND & HIGH FLOW FEMORAL-VENTRICULAR PIGTAIL CATH Cordis Corp. | DQO |
| May 15, 1986 | K861483 | ANGIOGRAPHIC CATHETER (CARDIOLOGY & RADIOLOGY) Mallinckrodt Critical Care | DQO |
| May 8, 1986 | K860805 | PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337 Gould, Inc. | DQO |
| Apr 23, 1986 | K860429 | MEADOX SURGIMED GUIDE CATHETER Meadox Surgimed, Inc. | DQO |
| Mar 31, 1986 | K860580 | ACS BRACHIAL CORONARY GUIDING CATH W/TAPERED TIP Advanced Cardiovascular Systems, Inc. | DQO |
| Feb 26, 1986 | K854576 | MODIFIED CORDIS PTCA GUIDING CATHETERS Cordis Corp. | DQO |
| Feb 18, 1986 | K855103 | CIRIBART GYUDUBG CATGETER Mansfield Scientific, Inc. | DQO |
| Jan 16, 1986 | K854018 | ANGIOGRAPHY CATHETERS Micor, Inc. | DQO |
| Jan 15, 1986 | K853182 | DIAGNOSTIC INTRAVASCULAR CATHETERS Mallinckrodt Critical Care | DQO |
| Nov 6, 1985 | K852197 | LAP-CATH Research Medical, Inc. | DQO |
| Nov 1, 1985 | K852456 | FAP-CATH Research Medical, Inc. | DQO |
| Oct 11, 1985 | K852872 | ANGIOMEDICS SOFTIP CATHETER Angiomedics, Inc. | DQO |
| May 21, 1985 | K844854 | OPTI-FLOW DIGITAL SUBTRACTION ANGIOGRAPHY CAT-KIT Vas-Cath of Canada , Ltd., CA | DQO |
| May 16, 1985 | K851088 | UMI ANGIOGRAPHIC CATHETER Universal Medical Instrument Corp. | DQO |
| May 16, 1985 | K844800 | OPTI-FLOW & OPTI-TORQUE ANGIOGRAPHIC CATHETERS Vas-Cath of Canada , Ltd., CA | DQO |
| Apr 3, 1985 | K850271 | ANGIOMEDIC'S CATHETER-DIAGNOSTIC INTRAVASCULAR Angiomedics, Inc. | DQO |
| Mar 27, 1985 | K844555 | PATHFINDER CARDIOVASCULAR CATHETER Argon Medical Corp. | DQO |
| Feb 25, 1985 | K850341 | CARDIOVASCULAR SET UP Marwood Medical, Inc. | DQO |
| Feb 1, 1985 | K844598 | LARIAT CATHETER Mallinckrodt Critical Care | DQO |
| Jan 2, 1985 | K844161 | PTCA GUIDING CATHER Cordis Corp. | DQO |
| Oct 18, 1984 | K843726 | NAMIC ADB ANGIOGRAPHIC DUMP BAG North American Instrument Corp. | DQO |
| Aug 10, 1984 | K842799 | PERCUTANEOUS ANGIOSCOPE DELIVERY CATH American Edwards Laboratories | DQO |
| Aug 10, 1984 | K842798 | INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH American Edwards Laboratories | DQO |
| Jul 13, 1984 | K842195 | ADVANCED CARDIOVASCULAR-CORONARY GUID Advanced Cardiovascular Systems, Inc. | DQO |
| Jun 13, 1984 | K840763 | SILVERTORQUE CARDIAC CATHETERS Surgimed Corp. | DQO |
| Jun 5, 1984 | K841615 | ELECATH HEPARIN-COATED CATHETERS Electro-Catheter Corp. | DQO |
| Mar 12, 1984 | K833554 | MATERIAL ADDITION LEXAN & K-RESIN Procedure Products, Inc. | DQO |
| Feb 4, 1984 | K834459 | DIAGNOSTIC RADIOLOGY CATHETERS American Edwards Laboratories | DQO |
| Feb 4, 1984 | K834275 | SOFTIP CATHETER Angiomedics, Inc. | DQO |
| Oct 19, 1983 | K832386 | PERCLUDER DL OCCLUDING BALLOON Datascope Corp. | DQO |
| Jul 19, 1983 | K831337 | COMPRESSAR DISPOSABLE DISC Instromedix, Inc. | DQO |
| Jun 30, 1983 | K831562 | SONTEK INFUSION CATHETER Sontek Corp. | DQO |
| Jun 8, 1983 | K831509 | ANGIOGRAPHY KIT W/ADDIT. COMPONENTS Mallinckrodt Critical Care | DQO |
| May 25, 1983 | K831171 | DIGICATH Argon Medical Corp. | DQO |
| May 9, 1983 | K831189 | ANGIOGRAPHIC NEEDLE Medrad, Inc. | DQO |
| Apr 30, 1983 | K830788 | CENTRAL VEIN CATHERIZATION KIT-14-690- Norton Performance Plastics Corp. | DQO |
| Apr 28, 1983 | K830415 | DIAGNOSTIC INTRAVASCULAR CATHETER Mallinckrodt Critical Care | DQO |
| Apr 12, 1983 | K830734 | FORGARTY BALLOON CALIBRATOR American Edwards Laboratories | DQO |
| Mar 31, 1983 | K830025 | DIGITAL SUBTRACTION ANGIOGRAPHY CONVEN- Medrad/Technology For People | DQO |
| Mar 24, 1983 | K830637 | VERTEX DIGITAL SUBSTRATION KIT Professional Medical Services | DQO |
| Mar 24, 1983 | K823754 | SAHOTA-KAPLAN HEMOSTAT Erickson Industries, Inc. | DQO |
| Mar 17, 1983 | K830576 | LYMPHANGIOGRAPHY SET Vertex Medical Corp. | DQO |
| Mar 16, 1983 | K830523 | CATHETER CONNECTION W/INTEGRAL INJECTATE Gould, Inc. | DQO |
| Mar 11, 1983 | K823357 | VARIOUS CARDIOVASCULAR PRODUCTS C.R. Bard, Inc. | DQO |
| Feb 28, 1983 | K830420 | POLYETHYLENE MONITORING CONNECTORS Vertex Medical Corp. | DQO |
| Feb 23, 1983 | K823758 | CENTRAL VEIN CATHERIZATION KIT Access Devices, Inc. | DQO |
| Feb 18, 1983 | K830237 | TRANSLUCENT POLY. CATH. CONNECTOR AND Vertex Medical Corp. | DQO |
| Jan 27, 1983 | K823064 | INTRACATH-DA INTRAVENOUS CATH. PLACEMENT Parke-Davis Co. | DQO |
| Jan 21, 1983 | K830022 | S.M.P. CONTRAST MEDIA SET Omega Technologies, Inc. | DQO |
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