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 |
|---|---|---|---|
| Oct 16, 1997 | K962829 | HARMAC BALLOON ANGIOGRAPHIC CATHETER Harmac Medical Products, Inc. | DQO |
| Oct 10, 1997 | K965112 | MEDLINE CATHETERIZATION LABORATORY TRAYS/KITS/PACKS Medline Industries, Inc. | DQO |
| Sep 30, 1997 | K970854 | 5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER Cordis Corp. | DQO |
| Jul 31, 1997 | K970207 | MEDI-TECH 5 FRENCH NIGHTHAWK SELECTIVE ANGIOGRAPHIC CATHETERS Boston Scientific Corp | DQO |
| Jul 24, 1997 | K971607 | MEDI-TECH 4 AND 5 FRENCH NIGHTHAWK FLUSH ANGIOGRAPHIC CATHETERS Boston Scientific Corp | DQO |
| Jul 14, 1997 | K971646 | 4F NYLEX ANGIOGRAPHY CATHETER/5F NYLEX ANGIOGRAPHY CATHETER Cordis Corp. | DQO |
| May 28, 1997 | K971034 | USCI MAINSTAY GUIDING CATHETER C.R. Bard, Inc. | DQO |
| May 8, 1997 | K970469 | EVT ANGIOSCALE ANGIOGRAPHIC CATHETER Guidant Cardiac and Vascular Surgery | DQO |
| May 6, 1997 | K964033 | 3F ANGIOPTIC ANGIOGRAPHIC CATHETER AngioDynamics, Inc. | DQO |
| Feb 21, 1997 | K965249 | SPYGLASS ANGIOGRAPHIC CATHETER Daig Corp. | DQO |
| Feb 10, 1997 | K964859 | SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS Scimed Life Systems, Inc. | DQO |
| Jan 13, 1997 | K964331 | ASC HIGH PRESSURE BRAIDED TUBES Adam Spencer Corp. | DQO |
| Jan 13, 1997 | K963092 | MAXI-TORQUE PLUS SOFTIP ANGIOGRAPHIC CATHETER Adam Spencer Corp. | DQO |
| Oct 23, 1996 | K960056 | USCI PRO FLO XT,SOFT TIP, AND XT SOFT TIP ANGIOGRAPHIC C.R. Bard, Inc. | DQO |
| Oct 17, 1996 | K961499 | LAGUNA SOFTIP DIAGNOSTIC CATHETERS Boston Scientific Scimed, Inc. | DQO |
| Oct 15, 1996 | K962805 | SPYGLASS ANGIOGRAPHIC CATHETER Daig Corp. | DQO |
| Oct 10, 1996 | K962759 | 4F NYLEX ANGIOGRAPHIC CATHETER Cordis Corp. | DQO |
| May 2, 1996 | K960806 | TURBO TRACKER Target Therapeutics | DQO |
| Apr 2, 1996 | K960975 | 1-4F INFINITI ANGIOGRAPHIC CATHETER Cordis Corp. | DQO |
| Apr 2, 1996 | K960070 | NUMED ATRIOSEPTOSTOMY CATHETER NuMED, Inc. | DQO |
| Mar 29, 1996 | K960801 | SELECTOR ANGIOGRAPHIC CATHETER (VARIOUS MODELS) North American Instrument Corp. | DQO |
| Feb 23, 1996 | K955485 | BRUN SELECTIVE AND FLUSH ANGIOGRAPHIC CATHETERS B.Braun Medical, Inc. | DQO |
| Jan 31, 1996 | K955111 | MAXI-TORQUE PLUS ANGIOGRAPHIC CATHETER Adam Spence Corp. | DQO |
| Jan 29, 1996 | K952984 | MAP MULTITRACK ANGIOGRAPHIC CATHETER (4F) Map Medical Equipment, Inc. | DQO |
| Dec 1, 1995 | K954423 | ANGIOPTIC ANGIOGRAPHIC CATHETER AngioDynamics, Inc. | DQO |
| Nov 7, 1995 | K952773 | MIKRO-TIP ANGIOGRAPHIC CATHETER Millar Instruments, Inc. | DQO |
| Oct 5, 1995 | K950398 | CATHETER, BALLOON TYPE Interventional Therapeutics Corp. | DQO |
| Sep 15, 1995 | K950440 | DUAL FUNCTION PACING WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD J-Lloyd Medical, Inc. | DQO |
| Sep 12, 1995 | K953114 | EVOLUTION MICROCATHETER Boston Scientific Corp | DQO |
| Aug 17, 1995 | K950882 | BRAUN SELECTIVE ANGIOGRAPHIC CATHETER B.Braun Medical, Inc. | DQO |
| Aug 8, 1995 | K950910 | TRANSIT-2 INFUSION CATHETER Cordis Neurovascular, Inc. | DQO |
| Jun 22, 1995 | K951720 | SCIMED EXPO ANGIOGRAPHIC CATHETER Scimed Life Systems, Inc. | DQO |
| Jun 13, 1995 | K942927 | 0.035 IN. WISE WIRE Boston Scientific Corp | DQO |
| May 30, 1995 | K950855 | ASE MAXI-TORQUE, SUPPLE FLEX ANGIOGRAPHIC CATHETERS Adam Spence Corp. | DQO |
| May 16, 1995 | K950909 | TRANSIT-2 INFUSION CATHETER Cordis Neurovascular, Inc. | DQO |
| Apr 5, 1995 | K950731 | SCIMED 6 FRENCH EXPO ANGIOGRAPHIC CATHETER Scimed Life Systems, Inc. | DQO |
| Mar 3, 1995 | K944284 | CONTROL Daig Corp. | DQO |
| Dec 21, 1994 | K935985 | DEROYAL CRITICAL CARE DISPOSABLE WASTE STATION Deroyal Industries, Inc. | DQO |
| Dec 13, 1994 | K941978 | HIGH PRESSURE TUBING Abbott Laboratories | DQO |
| Nov 22, 1994 | K943192 | SCIMED CHOICE(TM) PTCA GUIDE WIRE Scimed Life Systems, Inc. | DQO |
| Nov 15, 1994 | K943739 | SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER Mallinckrodt Medical | DQO |
| Sep 22, 1994 | K932141 | CARDIAC CATHETERIZATION KIT Abbott Laboratories | DQO |
| Aug 31, 1994 | K942939 | CORDIS STEADFAST MAGNETIC EXCHANGE SYSTEM Cordis Corp. | DQO |
| Aug 1, 1994 | K942231 | MICROVIEW II/MICRORAIL II CATHETERS Cardiovascular Imaging Systems, Inc. | DQO |
| Jul 18, 1994 | K936282 | TRANSIT INFUSION CATHETER (NEUROVASCULAR USE) Cordis Neurovascular, Inc. | DQO |
| Jul 11, 1994 | K931560 | CARDIAC CATHETERIZATION TRAY Clinipad Corp. | DQO |
| Jul 7, 1994 | K922455 | EVERT-O-CATH CATHETER American Biomaterials Corp. | DQO |
| Jun 20, 1994 | K942329 | HAND CONTROLLED SYRINGE Abbott Laboratories | DQO |
| Jun 14, 1994 | K942482 | PRESSURE MONITORING EXTENSION Surgical Technologies, Inc. | DQO |
| Jun 13, 1994 | K941254 | DYE MANAGEMENT SYSTEM Abbott Laboratories | DQO |
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