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 |
|---|---|---|---|
| Sep 4, 2002 | K022621 | BOSTON SCIENTIFIC IMAGER II 4F SELECTIVE ANGIOGRAPHIC CATHETER Boston Scientific Corp | DQO |
| May 2, 2002 | K021283 | GUIDANT BALLOON CATHETER, SEVERAL MODELS Guidant Corp. | DQO |
| Apr 26, 2002 | K021015 | ACIST PLUS 4 ANGIOGRAPHIC CATHETER Acist Medical Systems | DQO |
| Apr 17, 2002 | K020890 | SPYGLASS 4 FR ANGIOGRAPHICY CATHETER St Jude Medical | DQO |
| Mar 20, 2002 | K020316 | CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC VESSEL DILATOR; MODELS 466-P306AU & 466-P306BU Cordis Corp. | DQO |
| Mar 13, 2002 | K012983 | ACIST 4 FRENCH ANGIOGRAPHIC CATHETER Acist Medical Systems, Inc. | DQO |
| Mar 8, 2002 | K014054 | EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL Edwards Lifesciences, LLC | DQO |
| Jan 29, 2002 | K020012 | MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETER Boston Scientific/Medi-Tech | DQO |
| Jan 24, 2002 | K012749 | BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664 Biocardia, Inc. | DQO |
| Sep 7, 2001 | K011664 | IMAGER II ANGIOGRAPHIC CATHETER Boston Scientific/Medi-Tech | DQO |
| Jun 8, 2001 | K003288 | ORIGEN DUAL LUMEN CATHETER Origen Biomedical, Inc. | DQO |
| May 22, 2001 | K003105 | BIOSPHERE MEDICAL INFUSION CATHETER Biosphere Medical | DQO |
| May 16, 2001 | K011217 | CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH LAB KIT Abbott Laboratories | DQO |
| May 16, 2001 | K003086 | CONCENTRIC MICRO CATHETER, MODELS 90001 TO 90008 Concentric Medical, Inc. | DQO |
| May 11, 2001 | K003020 | CARDIAC FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / VOLUME CATHETER Cd Leycom BV, NL | DQO |
| Mar 29, 2001 | K010707 | ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975 Boston Scientific, Target | DQO |
| Mar 16, 2001 | K002254 | COOK PRESSURE MONITORING CATHETER Cook, Inc. | DQO |
| Jan 18, 2001 | K003938 | TRAK BACK II Jomed, Inc. | DQO |
| Jan 17, 2001 | K003901 | ANGIODYNAMICS SOFT-VU SIZING ANGIOGRAPHIC CATHETER AngioDynamics, Inc. | DQO |
| Jan 11, 2001 | K003902 | MULTITRACK ANGIOGRAPHIC CATHETER NuMED, Inc. | DQO |
| Oct 13, 2000 | K001578 | ANGIODYNAMICS SOFT-VU HYDROPHILIC COATED ANGIOGRAPHIC CATHETER AngioDynamics, Inc. | DQO |
| Sep 21, 2000 | K000825 | 4F-7F MEDI-DYNE TORQ FLOW XLB ANGIOGRAPHIC CATHETER Medi-Dyne, Inc. | DQO |
| Sep 11, 2000 | K002416 | GOLDEN-RULE SCALING CATHETER Medical Device Technologies, Inc. | DQO |
| Sep 6, 2000 | K000743 | BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020 Boston Scientific Scimed, Inc. | DQO |
| Jun 5, 2000 | K000820 | AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700 Endosonics Corp. | DQO |
| May 3, 2000 | K000579 | TEMPO AQUA ANGIOGRAPHIC CATHETER Cordis Corp. | DQO |
| Apr 21, 2000 | K000956 | MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS Boston Scientific Scimed, Inc. | DQO |
| Mar 29, 2000 | K000659 | MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT Merit Medical Systems, Inc. | DQO |
| Mar 1, 2000 | K993694 | MIKRO-TIP ANGIOGRAPHIC CATHETER Millar Instruments, Inc. | DQO |
| Dec 21, 1999 | K990173 | PATHFINDER II ANGIOGRAPHIC CATHETER Maxxim Medical | DQO |
| Dec 15, 1999 | K992631 | ACUNAV DIAGNOSTIC ULTRASOUND CATHETER Acuson Corp. | DQO |
| Oct 8, 1999 | K992347 | CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS Cordis Corp. | DQO |
| Aug 23, 1999 | K992123 | SCIMED IMPULSE ANGIOGRAPHIC CATHETERS Boston Scientific Scimed, Inc. | DQO |
| Aug 10, 1999 | K992051 | RADIFOCUS OPTITORQUE Terumo Medical Corp. | DQO |
| Jul 27, 1999 | K984627 | AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER Arterial Vascular Engineering, Inc. | DQO |
| Jul 21, 1999 | K992142 | SCIMED ANGIOGRAPHIC CATHETERS Scimed | DQO |
| May 26, 1999 | K991673 | CORDIS TEMPO ANGIOGRAPHY CATHETER Cordis Corp. | DQO |
| Feb 11, 1999 | K984258 | NEUROVASX SUB-MICROINFUSION CATHETER Neuro Vasx, Inc. | DQO |
| Dec 10, 1998 | K980973 | MEDTRONIC ANGIOGRAPHIC CATHETER Medtronics Interventional Vascular | DQO |
| Nov 4, 1998 | K971616 | BLOOD PRESSURE MEASUREMENT SYSTEM(DSPM-70) Data Sciences Intl., Inc. | DQO |
| Oct 19, 1998 | K982299 | SPYGLASS 5 FR ANGIOGRAPHIC CATHETER Daig Corp. | DQO |
| Oct 16, 1998 | K974774 | ENVY GUIDING CATHETER Cook, Inc. | DQO |
| Aug 18, 1998 | K981788 | SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER Scimed Life Systems, Inc. | DQO |
| Aug 11, 1998 | K982077 | SELECTOR DIAGNOSTIC CATHETER Boston Scientific Scimed, Inc. | DQO |
| Jul 10, 1998 | K981441 | HEART CATH TRAY, STERILE, DISPOSABLE Trinity Laboratories, Inc. | DQO |
| May 15, 1998 | K980575 | SITESEER ANGIOGRAPHIC CATHETER C.R. Bard, Inc. | DQO |
| Feb 23, 1998 | K974559 | SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS Scimed Life Systems, Inc. | DQO |
| Nov 18, 1997 | K973401 | TEMPO 4 ANGIOGRAPHY CATHETER (VARIOUS) Cordis Corp. | DQO |
| Oct 31, 1997 | K964210 | RETRIEVER II Target Therapeutics | DQO |
| Oct 16, 1997 | K963335 | HARMAC BALLOON WEDGE PRESSURE CATHETER Harmac Medical Products, Inc. | DQO |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.