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 21, 1983 | K823243 | SIDEARM Y-ADAPTOR American Edwards Laboratories | DQO |
| Dec 15, 1982 | K823065 | INTRA CATH-DSA INTRAVENOUS CATH PLACE. Parke-Davis Co. | DQO |
| Oct 18, 1982 | K822862 | BRACHIAL CORONARY GUIDING CATHETER Advanced Cardiovascular Systems, Inc. | DQO |
| Sep 28, 1982 | K822640 | CORONARY INFUSION KIT Mallinckrodt Critical Care | DQO |
| Sep 28, 1982 | K822598 | TEFLON PIGTAIL/PERCUTANEOUS CARDIOVAS Vertex Medical Corp. | DQO |
| Sep 28, 1982 | K822594 | POLYETHYLENE CARDIOVASCULAR CATHETER Vertex Medical Corp. | DQO |
| Sep 21, 1982 | K822596 | VERTEX PERCUTANEOUS PUNCTURE NEEDLE Vertex Medical Corp. | DQO |
| Aug 31, 1982 | K822290 | STERILE PROTECTIVE SLEEVE W/TOUGH-BORST Universal Medical Instrument Corp. | DQO |
| Aug 24, 1982 | K822243 | GUIDING CATHETER Interventional Medical, Inc. | DQO |
| Aug 24, 1982 | K822100 | HIGH PRESSURE CONTRAST INJECTION LINE Namic | DQO |
| Aug 24, 1982 | K822033 | BERMAN ANGIOGRAPHIC BALLOON CATHETER Ziehm International, Inc. | DQO |
| Aug 24, 1982 | K821816 | ANGIOGRAPHIC CATHETER Medi-Tech, Inc. | DQO |
| Jul 20, 1982 | K821976 | ANGIOGRAPHY KIT Mallinckrodt Critical Care | DQO |
| Jan 29, 1982 | K820001 | CORONARY INFUSION KIT Mallinckrodt Critical Care | DQO |
| Jan 29, 1982 | K813577 | PRESSURE INDICATOR-REGULATOR Advanced Catheter Systems | DQO |
| Jan 22, 1982 | K813624 | ADVANCED CATHETER SYSTEMS CORONARY GUID Advanced Catheter Systems | DQO |
| Jan 22, 1982 | K813623 | SIMPSON-ROBERT CORONARY GUIDING CATHET Advanced Catheter Systems | DQO |
| Jan 22, 1982 | K813622 | INDEFLATOR Advanced Catheter Systems | DQO |
| Nov 27, 1981 | K813142 | LEADER-CATH Exco, Inc. | DQO |
| Nov 27, 1981 | K813140 | VYGON EXTENSION TUBES & CONNECTORS Exco, Inc. | DQO |
| Nov 16, 1981 | K812999 | PET POLYETHYLENE TORQUE CATHETER Universal Medical Instrument Corp. | DQO |
| Apr 17, 1981 | K810508 | SONTEK ANGIOGRAPHIC CATHETER Sontek Corp. | DQO |
| Mar 27, 1981 | K803270 | GANZ CORONARY REPERFUSION CATHETER American Edwards Laboratories | DQO |
| Mar 11, 1981 | K810360 | BAIM TM CORONARY SINUS FLOW THERMAL Electro-Catheter Corp. | DQO |
| Mar 5, 1981 | K810412 | USCI CARDIOVASCULAR CATHETER C.R. Bard, Inc. | DQO |
| Dec 19, 1980 | K802945 | PRESSURE MONITORING SET Norton Performance Plastics Corp. | DQO |
| Oct 31, 1980 | K802629 | STERI-SLEEVE Cordis Corp. | DQO |
| Jun 30, 1980 | K801322 | MEDI-TRACE DISP. LINES FOR PHYSIO. PRESS Graphic Controls Corp. | DQO |
| Jun 30, 1980 | K801321 | PACKAGE FOR MEDI-TRACE PHYSIOLOGICAL PRE Graphic Controls Corp. | DQO |
| Apr 29, 1980 | K800622 | EXTENSION LINE Norton Performance Plastics Corp. | DQO |
| Apr 24, 1980 | K800618 | SINGLE, 2&3 WAY SOLUTION SETS #14-070 ET Norton Performance Plastics Corp. | DQO |
| Apr 16, 1980 | K800741 | CENTRAL VEIN CATHETERIZATION KIT Medical Components, Inc. | DQO |
| Apr 8, 1980 | K800703 | MODIFIED CATHETER PACKAGE Hancock Laboratories, Inc. | DQO |
| Mar 12, 1980 | K800461 | CENTRAL VENOUS PRESSURE CATHETER Medical Components, Inc. | DQO |
| Feb 1, 1980 | K800171 | DIAGNOSTIC INTRAVASCULAR CATHETER Flomed, Inc. | DQO |
| Dec 19, 1979 | K791915 | WHITE SEALING CAP Quinton, Inc. | DQO |
| Feb 1, 1979 | K790107 | CATHETER TUBING MODIFICATION Jelco Laboratories | DQO |
| Jan 25, 1979 | K790082 | ARTERIAL EXTENSION SET Namic | DQO |
| Jan 15, 1979 | K781819 | POST EXTRA SYSTOLIC POTENTIATOR Medrad, Inc. | DQO |
| Dec 20, 1978 | K782082 | CATHETER, DIGITAL POSITRAL II C.R. Bard, Inc. | DQO |
| Oct 10, 1978 | K781558 | PRESSURE MONITORING INJECTION LINES Cobe Laboratories, Inc. | DQO |
| May 9, 1978 | K780529 | MYOCATH KIT Sorensen Research | DQO |
| Nov 28, 1977 | K772175 | CATHETER SYSTEM, COPE/EISENBERG Victory Engineering Corp. | DQO |
| Nov 17, 1977 | K771810 | PRESSURE TUBING Pharmaseal Div., Baxter Healthcare Corp. | DQO |
| Jun 27, 1977 | K770868 | CATHETER, POLYURETHANE, W/STYLET Abbott Laboratories | DQO |
| Mar 15, 1977 | K770290 | MONITORING KIT, CENTRAL VENOUS PRESSURE Argon Medical Corp. | DQO |
| Mar 14, 1977 | K770462 | PUNCTURE KIT, INTERNAL JUGULAR Arrow Intl., Inc. | DQO |
| Nov 2, 1976 | K760388 | CATHETER, VEIN (VENOFIX) B. Braun Instruments | DQO |
| Nov 2, 1976 | K760387 | CATHETER, CAVA (CAVAFIX) B. Braun Instruments | DQO |
| Nov 2, 1976 | K760386 | CENTRAL VEINOUS PRESSURE SETS B. Braun Instruments | DQO |
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