FDA Product Code
FDA Product Code DQO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1200
510(k) Clearances — 501 records · page 5 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K860867 | DIGITAL SUBTRACTION ANGIOGRAPHY CATHETERS AND SETS | Medical Components, Inc. | 1986-07-02 | Traditional | PDF ↗ |
| K862006 | STAND & HIGH FLOW FEMORAL-VENTRICULAR PIGTAIL CATH | Cordis Corp. | 1986-06-27 | Traditional | PDF ↗ |
| K861483 | ANGIOGRAPHIC CATHETER (CARDIOLOGY & RADIOLOGY) | Mallinckrodt Critical Care | 1986-05-15 | Traditional | PDF ↗ |
| K860805 | PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337 | Gould, Inc. | 1986-05-08 | Traditional | PDF ↗ |
| K860429 | MEADOX SURGIMED GUIDE CATHETER | Meadox Surgimed, Inc. | 1986-04-23 | Traditional | PDF ↗ |
| K860580 | ACS BRACHIAL CORONARY GUIDING CATH W/TAPERED TIP | Advanced Cardiovascular Systems, Inc. | 1986-03-31 | Traditional | PDF ↗ |
| K854576 | MODIFIED CORDIS PTCA GUIDING CATHETERS | Cordis Corp. | 1986-02-26 | Traditional | PDF ↗ |
| K855103 | CIRIBART GYUDUBG CATGETER | Mansfield Scientific, Inc. | 1986-02-18 | Traditional | PDF ↗ |
| K854018 | ANGIOGRAPHY CATHETERS | Micor, Inc. | 1986-01-16 | Traditional | PDF ↗ |
| K853182 | DIAGNOSTIC INTRAVASCULAR CATHETERS | Mallinckrodt Critical Care | 1986-01-15 | Traditional | PDF ↗ |
| K852197 | LAP-CATH | Research Medical, Inc. | 1985-11-06 | Traditional | PDF ↗ |
| K852456 | FAP-CATH | Research Medical, Inc. | 1985-11-01 | Traditional | PDF ↗ |
| K852872 | ANGIOMEDICS SOFTIP CATHETER | Angiomedics, Inc. | 1985-10-11 | Traditional | PDF ↗ |
| K844854 | OPTI-FLOW DIGITAL SUBTRACTION ANGIOGRAPHY CAT-KIT | Vas-Cath of Canada , Ltd. | 1985-05-21 | Traditional | PDF ↗ |
| K844800 | OPTI-FLOW & OPTI-TORQUE ANGIOGRAPHIC CATHETERS | Vas-Cath of Canada , Ltd. | 1985-05-16 | Traditional | PDF ↗ |
| K851088 | UMI ANGIOGRAPHIC CATHETER | Universal Medical Instrument Corp. | 1985-05-16 | Traditional | PDF ↗ |
| K850271 | ANGIOMEDIC'S CATHETER-DIAGNOSTIC INTRAVASCULAR | Angiomedics, Inc. | 1985-04-03 | Traditional | PDF ↗ |
| K844555 | PATHFINDER CARDIOVASCULAR CATHETER | Argon Medical Corp. | 1985-03-27 | Traditional | PDF ↗ |
| K850341 | CARDIOVASCULAR SET UP | Marwood Medical, Inc. | 1985-02-25 | Traditional | PDF ↗ |
| K844598 | LARIAT CATHETER | Mallinckrodt Critical Care | 1985-02-01 | Traditional | PDF ↗ |
| K844161 | PTCA GUIDING CATHER | Cordis Corp. | 1985-01-02 | Traditional | PDF ↗ |
| K843726 | NAMIC ADB ANGIOGRAPHIC DUMP BAG | North American Instrument Corp. | 1984-10-18 | Traditional | PDF ↗ |
| K842798 | INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH | American Edwards Laboratories | 1984-08-10 | Traditional | PDF ↗ |
| K842799 | PERCUTANEOUS ANGIOSCOPE DELIVERY CATH | American Edwards Laboratories | 1984-08-10 | Traditional | PDF ↗ |
| K842195 | ADVANCED CARDIOVASCULAR-CORONARY GUID | Advanced Cardiovascular Systems, Inc. | 1984-07-13 | Traditional | PDF ↗ |
| K840763 | SILVERTORQUE CARDIAC CATHETERS | Surgimed Corp. | 1984-06-13 | Traditional | PDF ↗ |
| K841615 | ELECATH HEPARIN-COATED CATHETERS | Electro-Catheter Corp. | 1984-06-05 | Traditional | PDF ↗ |
| K833554 | MATERIAL ADDITION LEXAN & K-RESIN | Procedure Products, Inc. | 1984-03-12 | Traditional | PDF ↗ |
| K834459 | DIAGNOSTIC RADIOLOGY CATHETERS | American Edwards Laboratories | 1984-02-04 | Traditional | PDF ↗ |
| K834275 | SOFTIP CATHETER | Angiomedics, Inc. | 1984-02-04 | Traditional | PDF ↗ |
| K832386 | PERCLUDER DL OCCLUDING BALLOON | Datascope Corp. | 1983-10-19 | Traditional | PDF ↗ |
| K831337 | COMPRESSAR DISPOSABLE DISC | Instromedix, Inc. | 1983-07-19 | Traditional | PDF ↗ |
| K831562 | SONTEK INFUSION CATHETER | Sontek Corp. | 1983-06-30 | Traditional | PDF ↗ |
| K831509 | ANGIOGRAPHY KIT W/ADDIT. COMPONENTS | Mallinckrodt Critical Care | 1983-06-08 | Traditional | PDF ↗ |
| K831171 | DIGICATH | Argon Medical Corp. | 1983-05-25 | Traditional | PDF ↗ |
| K831189 | ANGIOGRAPHIC NEEDLE | Medrad, Inc. | 1983-05-09 | Traditional | PDF ↗ |
| K830788 | CENTRAL VEIN CATHERIZATION KIT-14-690- | Norton Performance Plastics Corp. | 1983-04-30 | Traditional | PDF ↗ |
| K830415 | DIAGNOSTIC INTRAVASCULAR CATHETER | Mallinckrodt Critical Care | 1983-04-28 | Traditional | PDF ↗ |
| K830734 | FORGARTY BALLOON CALIBRATOR | American Edwards Laboratories | 1983-04-12 | Traditional | PDF ↗ |
| K830025 | DIGITAL SUBTRACTION ANGIOGRAPHY CONVEN- | Medrad/Technology For People | 1983-03-31 | Traditional | PDF ↗ |
| K823754 | SAHOTA-KAPLAN HEMOSTAT | Erickson Industries, Inc. | 1983-03-24 | Traditional | PDF ↗ |
| K830637 | VERTEX DIGITAL SUBSTRATION KIT | Professional Medical Services | 1983-03-24 | Traditional | PDF ↗ |
| K830576 | LYMPHANGIOGRAPHY SET | Vertex Medical Corp. | 1983-03-17 | Traditional | PDF ↗ |
| K830523 | CATHETER CONNECTION W/INTEGRAL INJECTATE | Gould, Inc. | 1983-03-16 | Traditional | PDF ↗ |
| K823357 | VARIOUS CARDIOVASCULAR PRODUCTS | C.R. Bard, Inc. | 1983-03-11 | Traditional | PDF ↗ |
| K830420 | POLYETHYLENE MONITORING CONNECTORS | Vertex Medical Corp. | 1983-02-28 | Traditional | PDF ↗ |
| K823758 | CENTRAL VEIN CATHERIZATION KIT | Access Devices, Inc. | 1983-02-23 | Traditional | PDF ↗ |
| K830237 | TRANSLUCENT POLY. CATH. CONNECTOR AND | Vertex Medical Corp. | 1983-02-18 | Traditional | PDF ↗ |
| K823064 | INTRACATH-DA INTRAVENOUS CATH. PLACEMENT | Parke-Davis Co. | 1983-01-27 | Traditional | PDF ↗ |
| K830022 | S.M.P. CONTRAST MEDIA SET | Omega Technologies, Inc. | 1983-01-21 | Traditional | PDF ↗ |
| K823243 | SIDEARM Y-ADAPTOR | American Edwards Laboratories | 1983-01-21 | Traditional | PDF ↗ |
| K823065 | INTRA CATH-DSA INTRAVENOUS CATH PLACE. | Parke-Davis Co. | 1982-12-15 | Traditional | PDF ↗ |
| K822862 | BRACHIAL CORONARY GUIDING CATHETER | Advanced Cardiovascular Systems, Inc. | 1982-10-18 | Traditional | PDF ↗ |
| K822594 | POLYETHYLENE CARDIOVASCULAR CATHETER | Vertex Medical Corp. | 1982-09-28 | Traditional | PDF ↗ |
| K822598 | TEFLON PIGTAIL/PERCUTANEOUS CARDIOVAS | Vertex Medical Corp. | 1982-09-28 | Traditional | PDF ↗ |
| K822640 | CORONARY INFUSION KIT | Mallinckrodt Critical Care | 1982-09-28 | Traditional | PDF ↗ |
| K822596 | VERTEX PERCUTANEOUS PUNCTURE NEEDLE | Vertex Medical Corp. | 1982-09-21 | Traditional | PDF ↗ |
| K822290 | STERILE PROTECTIVE SLEEVE W/TOUGH-BORST | Universal Medical Instrument Corp. | 1982-08-31 | Traditional | PDF ↗ |
| K822100 | HIGH PRESSURE CONTRAST INJECTION LINE | Namic | 1982-08-24 | Traditional | PDF ↗ |
| K822243 | GUIDING CATHETER | Interventional Medical, Inc. | 1982-08-24 | Traditional | PDF ↗ |
| K821816 | ANGIOGRAPHIC CATHETER | Medi-Tech, Inc. | 1982-08-24 | Traditional | PDF ↗ |
| K822033 | BERMAN ANGIOGRAPHIC BALLOON CATHETER | Ziehm International, Inc. | 1982-08-24 | Traditional | PDF ↗ |
| K821976 | ANGIOGRAPHY KIT | Mallinckrodt Critical Care | 1982-07-20 | Traditional | PDF ↗ |
| K820001 | CORONARY INFUSION KIT | Mallinckrodt Critical Care | 1982-01-29 | Traditional | PDF ↗ |
| K813577 | PRESSURE INDICATOR-REGULATOR | Advanced Catheter Systems | 1982-01-29 | Traditional | PDF ↗ |
| K813624 | ADVANCED CATHETER SYSTEMS CORONARY GUID | Advanced Catheter Systems | 1982-01-22 | Traditional | PDF ↗ |
| K813623 | SIMPSON-ROBERT CORONARY GUIDING CATHET | Advanced Catheter Systems | 1982-01-22 | Traditional | PDF ↗ |
| K813622 | INDEFLATOR | Advanced Catheter Systems | 1982-01-22 | Traditional | PDF ↗ |
| K813140 | VYGON EXTENSION TUBES & CONNECTORS | Exco, Inc. | 1981-11-27 | Traditional | PDF ↗ |
| K813142 | LEADER-CATH | Exco, Inc. | 1981-11-27 | Traditional | PDF ↗ |
| K812999 | PET POLYETHYLENE TORQUE CATHETER | Universal Medical Instrument Corp. | 1981-11-16 | Traditional | PDF ↗ |
| K810508 | SONTEK ANGIOGRAPHIC CATHETER | Sontek Corp. | 1981-04-17 | Traditional | PDF ↗ |
| K803270 | GANZ CORONARY REPERFUSION CATHETER | American Edwards Laboratories | 1981-03-27 | Traditional | PDF ↗ |
| K810360 | BAIM TM CORONARY SINUS FLOW THERMAL | Electro-Catheter Corp. | 1981-03-11 | Traditional | PDF ↗ |
| K810412 | USCI CARDIOVASCULAR CATHETER | C.R. Bard, Inc. | 1981-03-05 | Traditional | PDF ↗ |
| K802945 | PRESSURE MONITORING SET | Norton Performance Plastics Corp. | 1980-12-19 | Traditional | PDF ↗ |
| K802629 | STERI-SLEEVE | Cordis Corp. | 1980-10-31 | Traditional | PDF ↗ |
| K801321 | PACKAGE FOR MEDI-TRACE PHYSIOLOGICAL PRE | Graphic Controls Corp. | 1980-06-30 | Traditional | PDF ↗ |
| K801322 | MEDI-TRACE DISP. LINES FOR PHYSIO. PRESS | Graphic Controls Corp. | 1980-06-30 | Traditional | PDF ↗ |
| K800622 | EXTENSION LINE | Norton Performance Plastics Corp. | 1980-04-29 | Traditional | PDF ↗ |
| K800618 | SINGLE, 2&3 WAY SOLUTION SETS #14-070 ET | Norton Performance Plastics Corp. | 1980-04-24 | Traditional | PDF ↗ |
| K800741 | CENTRAL VEIN CATHETERIZATION KIT | Medical Components, Inc. | 1980-04-16 | Traditional | PDF ↗ |
| K800703 | MODIFIED CATHETER PACKAGE | Hancock Laboratories, Inc. | 1980-04-08 | Traditional | PDF ↗ |
| K800461 | CENTRAL VENOUS PRESSURE CATHETER | Medical Components, Inc. | 1980-03-12 | Traditional | PDF ↗ |
| K800171 | DIAGNOSTIC INTRAVASCULAR CATHETER | Flomed, Inc. | 1980-02-01 | Traditional | PDF ↗ |
| K791915 | WHITE SEALING CAP | Quinton, Inc. | 1979-12-19 | Traditional | PDF ↗ |
| K790107 | CATHETER TUBING MODIFICATION | Jelco Laboratories | 1979-02-01 | Traditional | PDF ↗ |
| K790082 | ARTERIAL EXTENSION SET | Namic | 1979-01-25 | Traditional | PDF ↗ |
| K781819 | POST EXTRA SYSTOLIC POTENTIATOR | Medrad, Inc. | 1979-01-15 | Traditional | PDF ↗ |
| K782082 | CATHETER, DIGITAL POSITRAL II | C.R. Bard, Inc. | 1978-12-20 | Traditional | PDF ↗ |
| K781558 | PRESSURE MONITORING INJECTION LINES | Cobe Laboratories, Inc. | 1978-10-10 | Traditional | PDF ↗ |
| K780529 | MYOCATH KIT | Sorensen Research | 1978-05-09 | Traditional | PDF ↗ |
| K772175 | CATHETER SYSTEM, COPE/EISENBERG | Victory Engineering Corp. | 1977-11-28 | Traditional | PDF ↗ |
| K771810 | PRESSURE TUBING | Pharmaseal Div., Baxter Healthcare Corp. | 1977-11-17 | Traditional | PDF ↗ |
| K770868 | CATHETER, POLYURETHANE, W/STYLET | Abbott Laboratories | 1977-06-27 | Traditional | PDF ↗ |
| K770290 | MONITORING KIT, CENTRAL VENOUS PRESSURE | Argon Medical Corp. | 1977-03-15 | Traditional | PDF ↗ |
| K770462 | PUNCTURE KIT, INTERNAL JUGULAR | Arrow Intl., Inc. | 1977-03-14 | Traditional | PDF ↗ |
| K760388 | CATHETER, VEIN (VENOFIX) | B. Braun Instruments | 1976-11-02 | Traditional | PDF ↗ |
| K760387 | CATHETER, CAVA (CAVAFIX) | B. Braun Instruments | 1976-11-02 | Traditional | PDF ↗ |
| K760386 | CENTRAL VEINOUS PRESSURE SETS | B. Braun Instruments | 1976-11-02 | Traditional | PDF ↗ |
Product code DQO · Class II · Cardiovascular. Data: openFDA.