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 4 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K911270 | LEOCOR GUIDING CATHETER | Leocor, Inc. | 1992-01-17 | Traditional | PDF ↗ |
| K914208 | MERIT DISPOSAL DEPOT(TM) | Merit Medical Systems, Inc. | 1991-12-18 | Traditional | PDF ↗ |
| K914199 | ANGIOGRAPHIC SOFT TIP CATHETER | E-Z-Em, Inc. | 1991-12-18 | Traditional | PDF ↗ |
| K912532 | ITC HIESHIMA TAPER SELECT(TM) PERCUTANEOUS CATH | Interventional Therapeutics Corp. | 1991-12-11 | Traditional | PDF ↗ |
| K914067 | RETRIEVAL DEVICE | Target Therapeutics | 1991-12-10 | Traditional | PDF ↗ |
| K914009 | SCHNEIDER SOFTIP(R) A+(TM) ANGIOGRAPHIC CATHETER | Schneider Intl., Ltd. | 1991-12-06 | Traditional | PDF ↗ |
| K914128 | CONNECTING SET | Procedure Products, Inc. | 1991-11-27 | Traditional | PDF ↗ |
| K913871 | FLOSWITCH(R) HP | Boston Scientific Corp | 1991-11-25 | Traditional | PDF ↗ |
| K914312 | SCIMED 7FR AND 8FR TRIGUIDE GUIDING CATHETERS | Scimed Life Systems, Inc. | 1991-11-22 | Traditional | PDF ↗ |
| K913682 | MERIT CUSTOM KIT | Merit Medical Systems, Inc. | 1991-11-15 | Traditional | PDF ↗ |
| K912477 | ITC COAXIAL ANGIOGRAPHIC CATH SET, MODIFICATION | Interventional Therapeutics Corp. | 1991-11-05 | Traditional | PDF ↗ |
| K913397 | MEGA ANGIOGRAM KIT | Mega Medical, Inc. | 1991-10-31 | Traditional | PDF ↗ |
| K911710 | HEPARIN COATED THERMODILUTION CATH & ACCESSORIES | Sunscope Intl., Inc. | 1991-10-23 | Traditional | PDF ↗ |
| K914141 | CORDIS DUAL LUMEN PRESSURE MONITORING CATHETER | Cordis Corp. | 1991-10-23 | Traditional | PDF ↗ |
| K914007 | CORDIS 5.2 FRENCH SUPER TORQUE PLUS CARDIO CATH | Cordis Corp. | 1991-10-18 | Traditional | PDF ↗ |
| K911957 | ACS RX SUPPORT CATHETER | Advanced Cardiovascular Systems, Inc. | 1991-09-06 | Traditional | PDF ↗ |
| K913364 | SCIMED 7 FR. & 8 FR. | Scimed Life Systems, Inc. | 1991-08-30 | Traditional | PDF ↗ |
| K912076 | POLY BRAIDED PIGTAIL/PERC CARD CATH W/VAR TIP CONF | The R Group | 1991-07-30 | Traditional | PDF ↗ |
| K911605 | TRACKER UNIBODY, UNIBODY W/SIDE & 25 SIDE HOLES | Target Therapeutics | 1991-07-09 | Traditional | PDF ↗ |
| K911560 | ZEPHYR INFUSION CATHETER | Target Therapeutics | 1991-07-05 | Traditional | PDF ↗ |
| K911703 | CORDIS 8 FRENCH 0.084 I.D. PTCA GUIDING CATHETER | Cordis Corp. | 1991-06-28 | Traditional | PDF ↗ |
| K911367 | BAXTER MARATHON(TM) INTRAVASCULAR RELAY GUID CATH | Baxter Healthcare Corp | 1991-06-10 | Traditional | PDF ↗ |
| K910987 | 7FR. AND 8FR. TRIGUIDE GUIDING CATHETER ADD. CURVE | Scimed | 1991-05-29 | Traditional | PDF ↗ |
| K910204 | SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM) | Baxter Healthcare Corp | 1991-04-24 | Traditional | PDF ↗ |
| K910378 | PRESSURE MONITORING EXTENSION LINE | Professional Medical Services | 1991-04-22 | Traditional | PDF ↗ |
| K910259 | SCHNEIDER MAGNARAIL PROBING CATHETER | Schneider Intl., Ltd. | 1991-04-18 | Traditional | PDF ↗ |
| K904618 | CVIS INSIGHT IMAGING CATHETER | Cardiovascular Imaging Systems, Inc. | 1991-04-12 | Traditional | PDF ↗ |
| K910208 | BAXTER MARATHON(R) INTRAVASCULAR GUIDING CATHETERS | Baxter Healthcare Corp | 1991-04-01 | Traditional | PDF ↗ |
| K903848 | DIAGNOSTIC INTRASCULAR CATHETER | Applied Vascular Devices, Inc. | 1991-03-25 | Traditional | PDF ↗ |
| K905715 | ACS ANGIOSCOPIC CATHETER | Advanced Cardiovascular Systems, Inc. | 1991-03-18 | Traditional | PDF ↗ |
| K905625 | CVIS INSIGHT IMAGING CATHETER | Cardiovascular Imaging Systems, Inc. | 1991-02-21 | Traditional | PDF ↗ |
| K905499 | SCIMD 7 FR. TRIGUIDE GUIDING CATHETER | Scimed Life Systems, Inc. | 1991-02-11 | Traditional | PDF ↗ |
| K905297 | DIAVENTIONAL CATHETER | Cordis Corp. | 1991-02-01 | Traditional | PDF ↗ |
| K904491 | TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000 | Lifestream Int'L, Inc. | 1991-02-01 | Traditional | PDF ↗ |
| K905727 | USCI SATIN FINISH SOFT TIP ANGIOGRAPHIC CATHETER | C.R. Bard, Inc. | 1991-02-01 | Traditional | PDF ↗ |
| K905018 | LAB-SITE SAFETY NEEDLE | Telos Medical Corp. | 1991-01-16 | Traditional | PDF ↗ |
| K905017 | LAB-SITE | Telos Medical Corp. | 1991-01-15 | Traditional | PDF ↗ |
| K904788 | MEWISSEN CATHETER | Boston Scientific Corp | 1990-12-17 | Traditional | PDF ↗ |
| K903199 | HOLLOW LUMEN NEEDLE, PART NUMBER: MX920 | Medex, Inc. | 1990-12-17 | Traditional | PDF ↗ |
| K892671 | WILSON BIOMEDICAL ANGIOGRAPHIC CATHETER | Wilson Biomedical, Inc. | 1990-12-17 | Traditional | PDF ↗ |
| K904959 | PSG HEMOSTATIC CONTROL VALVE | Peripheral Systems Group | 1990-12-17 | Traditional | PDF ↗ |
| K902771 | ARTERIAL BLOOD SAMPLING KIT | Medex, Inc. | 1990-11-05 | Traditional | PDF ↗ |
| K902943 | RSI FEMORAL GUIDING CATHETER | Retroperfusion Systems, Inc. | 1990-10-03 | Traditional | PDF ↗ |
| K902953 | SOFTOUCH GUIDING CATHETER | Mallinckrodt Medical | 1990-09-28 | Traditional | PDF ↗ |
| K900460 | MODIFIED NOVOSTE ANGIOGRAPHIC CATHETER | Novoste Corp. | 1990-07-17 | Traditional | PDF ↗ |
| K901691 | CVIS INSIGHT 15MHZ CATHETERS FOR PERIPHERAL USE | Cardiovascular Imaging Systems, Inc. | 1990-07-06 | Traditional | PDF ↗ |
| K895437 | SCIMED CORONARY GUIDING CATHETER | Scimed Life Systems, Inc. | 1990-06-28 | Traditional | PDF ↗ |
| K895180 | USCI 7F LARGE LUMEN GUIDING CATHETER | C.R. Bard, Inc. | 1990-04-23 | Traditional | PDF ↗ |
| K894401 | BALLOON THERMODILUTION CATHETERS | Worldwide Medical | 1990-04-19 | Traditional | PDF ↗ |
| K895542 | SONICATH(TM) 5 F | Boston Scientific Corp | 1990-04-06 | Traditional | PDF ↗ |
| K896308 | CORDIS SHUTTLE CATHETER | Cordis Corp. | 1990-03-28 | Traditional | PDF ↗ |
| K897051 | MILLER PERCUTANEOUS ANGIOGRAPHIC/SCOPIC IRRI. CATH | Cathlab Corp. | 1990-03-16 | Traditional | PDF ↗ |
| K896741 | SCHNEIDER MONORAIL-PMC PRESSURE MONITORING CATH. | Schneider Intl., Ltd. | 1990-02-28 | Traditional | PDF ↗ |
| K896690 | MODIFIED ANGIOGRAPHIC CATHETER | Novoste Corp. | 1990-01-24 | Traditional | PDF ↗ |
| K895146 | GUIDING CATHETER | Peripheral Systems Group | 1990-01-19 | Traditional | PDF ↗ |
| K885221 | MULTILUMEN CENTRAL VENOUS CATHETER | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-12-28 | Traditional | PDF ↗ |
| K893877 | BIOCHEM 3100 OXIMETER | Biochem International, Inc. | 1989-12-20 | Traditional | PDF ↗ |
| K894168 | SWAN-GANZ THERM CATH SM HEART AMC THROM 93A102H5F | Baxter Healthcare Corp | 1989-11-27 | Traditional | PDF ↗ |
| K895268 | ARROW HANDS-OFF THERMO-PACE | Arrow Intl., Inc. | 1989-11-06 | Traditional | PDF ↗ |
| K893830 | HEMO-ALERT | Koregon Enterprise, Inc. | 1989-10-12 | Traditional | PDF ↗ |
| K891580 | INTRAVASCULAR CATHETER WITH HYDROPHILIC COATING | Boston Scientific Corp | 1989-08-03 | Traditional | PDF ↗ |
| K890206 | E-Z-FLOW ANGIOGRAPHY CATHETERS | E-Z-Em, Inc. | 1989-05-19 | Traditional | PDF ↗ |
| K885348 | A-V(TM) SOFTOUCH UHF CARDIAC PIGTAIL | Mallinckroot, Inc. | 1989-05-15 | Traditional | PDF ↗ |
| K890420 | USCI 7F GUIDE CATHETER | C.R. Bard, Inc. | 1989-04-24 | Traditional | PDF ↗ |
| K884354 | IMAGER FLUSH CATHETERS | Medi-Tech, Inc. | 1989-04-21 | Traditional | PDF ↗ |
| K882658 | ANGIOSCOPE FOR PULMONARY ARTERY USE | Washington Regulatory Services | 1989-01-26 | Traditional | PDF ↗ |
| K884502 | USCI 8F EXTRA LARGE LUMEN GUIDE CATHETER | C.R. Bard, Inc. | 1989-01-18 | Traditional | PDF ↗ |
| K884065 | CATH LAB MONITORING CATHETER | C.R. Bard, Inc. | 1989-01-12 | Traditional | PDF ↗ |
| K883651 | MILLAR MIKRO-TIP CATHETER PRESSURE TRANSDUCER | Millar Instruments, Inc. | 1988-11-18 | Traditional | PDF ↗ |
| K883051 | USCI SOFT-TIP ANGIOGRAPHIC CATHETER | C.R. Bard, Inc. | 1988-10-06 | Traditional | PDF ↗ |
| K882655 | PROCEDURE PACKS PRESS. MONITOR/ADMINISTRATION LINE | Procedure Packs, Inc. | 1988-09-16 | Traditional | PDF ↗ |
| K875127 | NOVOSTE 4, 4.2, 5 AND 6 FRENCH CATHETERS | Novoste Corp. | 1988-08-09 | Traditional | PDF ↗ |
| K882796 | SLIP-COAT(TM) CATHETERS | Cook, Inc. | 1988-07-28 | Traditional | PDF ↗ |
| K875337 | HEPARIN COATED LUMINAL PACING CATHETER | Spectramed, Inc. | 1988-05-25 | Traditional | PDF ↗ |
| K880661 | FIBEROPTIC CATHETER | Optimed Technologies, Inc. | 1988-05-02 | Traditional | PDF ↗ |
| K875326 | MODIFIED SCHNEIDER-SHILEY FLUSHING CATHETER | Schneider-Shilley (Usa) | 1988-02-18 | Traditional | PDF ↗ |
| K875325 | MODIFIED OCCLUDER/FLUSHING CATHETER STOPCOCK | Schneider-Shilley (Usa) | 1988-02-18 | Traditional | PDF ↗ |
| K874815 | TARGET THERAPEUTICS STERILE PRODUCTS | Target Therapeutics | 1988-02-05 | Traditional | PDF ↗ |
| K874037 | ANGIO WASTE FLUIDS DUMP BAG | Procedure Products, Inc. | 1988-01-29 | Traditional | PDF ↗ |
| K870700 | MICRO-GUIDE | Catheter Research C/O Burditt, Bowles & Radzius | 1987-12-03 | Traditional | PDF ↗ |
| K873438 | USCI (R) 8F LARGE LUMEN SOFT TIP GUIDE CATHETER | C.R. Bard, Inc. | 1987-11-27 | Traditional | PDF ↗ |
| K873004 | GUIDING CATHETER | Mallinckrodt Critical Care | 1987-09-15 | Traditional | PDF ↗ |
| K872248 | DOUBLE LUMEN CATHETER | Cordis Corp. | 1987-08-12 | Traditional | PDF ↗ |
| K871021 | GUIDING CATHETERS 9F JL4 | Devices For Vascular Intervention, Inc. | 1987-06-16 | Traditional | PDF ↗ |
| K870419 | IVR-SP CUSTOM ANGIOGRAPHY TRAY | North Coast Medi-Tek | 1987-05-11 | Traditional | PDF ↗ |
| K864943 | NUMED BALLOON WEDGE PRESSURE CATHETER | NuMED, Inc. | 1987-02-20 | Traditional | PDF ↗ |
| K864940 | NUMED BALLOON ANGIOGRAPHIC CATHETERS | NuMED, Inc. | 1987-02-19 | Traditional | PDF ↗ |
| K861241 | ANGIOTOPO CATHETER | Houston Biomedical, Inc. | 1987-01-06 | Traditional | PDF ↗ |
| K852547 | CORTRONIC APM 770 NONINVASIVE & ARTERIAL PRESS MON | Cortronic Corp. | 1986-11-10 | Traditional | PDF ↗ |
| K864141 | CORDIS CONTRAST INJECTION LINES | Cordis Corp. | 1986-11-03 | Traditional | PDF ↗ |
| K863137 | TERUMO RADIFOCUS ANGIOGRAPHIC CATHETER | Terumo Medical Corp. | 1986-10-10 | Traditional | PDF ↗ |
| K863337 | CORDIPAK CARDIAC CATHETERIZATION PACK | Angi-Pak Corp. | 1986-09-29 | Traditional | PDF ↗ |
| K862673 | MODEL 6615 FLOSCAN DOPPLER DIAGNOSTIC CATHETER | Medtronic Vascular | 1986-09-11 | Traditional | PDF ↗ |
| K862466 | SCHNEIDER-SHILEY FLUSHING CATHETER | Shiley, Inc. | 1986-08-29 | Traditional | PDF ↗ |
| K862464 | SCHNEIDER-SHILEY Y-CONNECTOR WITH ROTATOR | Shiley, Inc. | 1986-08-28 | Traditional | PDF ↗ |
| K862244 | MODIFICATIONS TO CORDIS' SUPER FLOW CATHETERS | Cordis Corp. | 1986-08-25 | Traditional | PDF ↗ |
| K862465 | SCHNEIDER-SHILEY OCCLUDER/FLUSHING CATH. STOPCOCK | Shiley, Inc. | 1986-08-11 | Traditional | PDF ↗ |
| K862030 | POLY-TECH ANGIOGRAPHY CATHETER | Poly-Tech Medical Device Research & Development | 1986-08-08 | Traditional | PDF ↗ |
| K854910 | ANGIOFLOW | Angiomed U.S., Inc. | 1986-07-17 | Traditional | PDF ↗ |
| K861236 | ACS CORONARY GUIDING CATHETER | Advanced Cardiovascular Systems, Inc. | 1986-07-10 | Traditional | PDF ↗ |
Product code DQO · Class II · Cardiovascular. Data: openFDA.