FDA Product Code
FDA Product Code DWF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4210
510(k) Clearances — 403 records · page 3 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K972665 | CHASE BLOOD VESSEL SHUNT | Chase Medical, Inc. | 1997-08-22 | Traditional | PDF ↗ |
| K971021 | CHASE PHRENIC NERVE PAD | Chase Medical, Inc. | 1997-08-12 | Traditional | PDF ↗ |
| K971019 | CHASE VESSEL CANNULA | Chase Medical, Inc. | 1997-07-21 | Traditional | PDF ↗ |
| K964373 | SARNS ARTERIAL CANNULAE WITH DURAFLO TREATMENT | 3M Healthcare | 1997-06-18 | Traditional | PDF ↗ |
| K964374 | SARNS VENOUS RETURN CATHETERS WITH DURAFLO TREATMENT | 3M Healthcare | 1997-06-18 | Traditional | PDF ↗ |
| K971291 | HEARTPORT ENDOARTERIAL RETURN CANNULA | Heartport, Inc. | 1997-06-17 | Traditional | PDF ↗ |
| K964391 | CHASE LEFT VENT SAFETY VALVE | Chase Medical, Inc. | 1997-05-13 | Traditional | PDF ↗ |
| K971041 | CHASE CORONARY OSTIAL PERFUSION CANNULA | Chase Medical, Inc. | 1997-05-13 | Traditional | PDF ↗ |
| K970914 | CHASE AORTIC PERFUSION CANNULA | Chase Medical, Inc. | 1997-05-13 | Traditional | PDF ↗ |
| K964393 | CHASE RETROGRADE CARDIOPLEGIA CANNULA | Chase Medical, Inc. | 1997-04-23 | Traditional | PDF ↗ |
| K964194 | CHASE CURVED LEFT HEART VENT CATHETER | Chase Medical, Inc. | 1997-04-16 | Traditional | PDF ↗ |
| K964200 | CHASE MULTIPLE PERFUSION SET | Chase Medical, Inc. | 1997-04-16 | Traditional | PDF ↗ |
| K964193 | CHASE AORTIC ARCH CANNULA | Chase Medical, Inc. | 1997-04-16 | Traditional | PDF ↗ |
| K964199 | CHASE CORONARY SINUS PERFUSION CANNULA | Chase Medical, Inc. | 1997-03-19 | Traditional | PDF ↗ |
| K964198 | CAHSE AORTIC ROOT CANNULA | Chase Medical, Inc. | 1997-03-19 | Traditional | PDF ↗ |
| K964195 | CHASE TWO STAGE VENOUS RETURN CATHETER | Chase Medical, Inc. | 1997-03-19 | Traditional | PDF ↗ |
| K962835 | HEARTPORT ENDOVENOUS DRAINAGE CANNULA | Heartport, Inc. | 1997-02-10 | Traditional | PDF ↗ |
| K964248 | HEARTPORT ENDOCORONARY SINUS CATHETR | Heartport, Inc. | 1997-01-22 | Traditional | PDF ↗ |
| K961594 | BETTER-VENTER | Circulatory Technology, Inc. | 1996-09-05 | Traditional | PDF ↗ |
| K961927 | RMI HEMOCONCENTRACTOR TUBING SET | Research Medical, Inc. | 1996-08-13 | Traditional | PDF ↗ |
| K961717 | NMI RETROGRADE CARDIOPLEGIA CANNULA-RCCS | Naltiac Medical, Inc. | 1996-07-18 | Traditional | PDF ↗ |
| K961180 | NMI ANTEGRAD CARDIOPLEGIA CANNULA | Naltiac Medical, Inc. | 1996-06-21 | Traditional | PDF ↗ |
| K961270 | HEARTPORT ENDOSINUS CATHETER | Heartport, Inc. | 1996-06-18 | Traditional | PDF ↗ |
| K961245 | HEARTPORT ENDOPULMONARY VENT | Heartport, Inc. | 1996-06-18 | Traditional | PDF ↗ |
| K955121 | HEARTPORT ENDOARTERIAL RETURN CANNUAL | Heartport, Inc. | 1996-05-10 | Traditional | PDF ↗ |
| K953945 | RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLET | Dlp, Inc. | 1996-03-26 | Traditional | PDF ↗ |
| K955818 | FOAMSEAL RETROGRADE CARDIOPLEGIA CATHETER | Quest Medical, Inc. | 1996-03-26 | Traditional | PDF ↗ |
| K951088 | QUEST RETROGRADE CARDIPLEGIA CANNULA-RCCS | Quest Medical, Inc. | 1995-06-14 | Traditional | PDF ↗ |
| K943934 | AORTIC ARCH CANNULAS | Sorin Group Italia S.R.L. | 1995-06-02 | Traditional | PDF ↗ |
| K950814 | QUEST ANTEGRADE CARDIOPLEGIA CANNULA | Quest Medical, Inc. | 1995-05-25 | Traditional | PDF ↗ |
| K941916 | QUEST CORONARY SINUS PERFUSION CANNULA -FRCC | Quest Medical, Inc. | 1995-04-06 | Traditional | PDF ↗ |
| K941166 | QUEST CORONARY SINUS PERFUSION CANNULA | Quest Medical, Inc. | 1995-01-17 | Traditional | PDF ↗ |
| K932208 | EXTRACORPOREAL CIRCUIT W/DURAFLO II HEPARIN TREATM | Baxter Healthcare Corp | 1994-08-09 | Traditional | PDF ↗ |
| K934127 | SARNS LOW JETTING AORTIC ARCH CANNULA | 3M Health Care, Sarns | 1994-02-22 | Traditional | PDF ↗ |
| K925049 | QUEST HEART INSULATION PAD | Quest Medical, Inc. | 1994-02-01 | Traditional | PDF ↗ |
| K931586 | VITAL-PORT MINI VASCULAR ACCESS SYSTEM | Med Institute, Inc. | 1993-09-27 | Traditional | PDF ↗ |
| K924529 | SIGNATURE(TM) CUSTOM TUBING PACK | Avecor Cardiovascular, Inc. | 1993-06-23 | Traditional | PDF ↗ |
| K925442 | SARNS RETROGRADE CANNULA | 3M Health Care, Sarns | 1993-05-21 | Traditional | PDF ↗ |
| K920902 | MODIFICATION OF SARNS TWO STAGE VENOUS CANNULA | 3M Health Care, Sarns | 1993-05-11 | Traditional | PDF ↗ |
| K930684 | BARD WILLIAM HARVEY TWO STAGE CANNULA | C.R. Bard, Inc. | 1993-05-11 | Traditional | PDF ↗ |
| K930620 | BARD(R) WILLIAM HARVEY(R) ARTERIAL STRAIGH CANNULA | C.R. Bard, Inc. | 1993-05-07 | Traditional | PDF ↗ |
| K930593 | BARD WILLIAM HARVEY AORTIC ROOT CARDIOPLEGIA CANNU | C.R. Bard, Inc. | 1993-05-06 | Traditional | PDF ↗ |
| K924642 | MEDTRONIC BIO-MEDICUS FEMORAL CANNULA/INTRODUCER | Medtronic Bio-Medicus, Inc. | 1993-03-26 | Traditional | PDF ↗ |
| K923483 | BARD WILLIAM HARVEY AORTIC ARCH CANULAE | C.R. Bard, Inc. | 1993-03-22 | Traditional | PDF ↗ |
| K922471 | SARNS RETROGRADE CANNULA - AUTO INFLATE | 3M Health Care, Sarns | 1993-03-12 | Traditional | PDF ↗ |
| K924643 | MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT | Medtronic Bio-Medicus, Inc. | 1992-12-08 | Traditional | PDF ↗ |
| K922992 | CONDUCER CARDIOPLEGIA SET SITH MP4 | 3M Health Care, Ltd. | 1992-09-18 | Traditional | PDF ↗ |
| K915268 | CATHETER TWO STAGE VENOUS RETURN | Dlp, Inc. | 1992-07-27 | Traditional | PDF ↗ |
| K915193 | SARNS RETROGRADE CANNULA | 3M Health Care, Sarns | 1992-03-04 | Traditional | PDF ↗ |
| K910004 | FURUI SHUNT, 2-WAY AND 3-WAY | Theramed, Inc. | 1991-09-19 | Traditional | PDF ↗ |
| K910021 | CARDIOPULMONARY BYPASS PUMP TUBING | Jtl Medical Corp. | 1991-05-22 | Traditional | PDF ↗ |
| K905224 | CARDIOPULMONARY BYPASS VASCULAR CATHETER | 3M Health Care, Sarns | 1991-02-05 | Traditional | PDF ↗ |
| K905638 | SARNS INVENT CATHETERS | 3M Health Care, Sarns | 1991-02-01 | Traditional | PDF ↗ |
| K905312 | DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS | Baxter Bentley Laboratories, Inc. | 1991-01-15 | Traditional | PDF ↗ |
| K902394 | RESUBMITTED MULTIORGAN PERFUSION CANNULA | Fresenius USA, Inc. | 1990-09-27 | Traditional | PDF ↗ |
| K902277 | BARD EXTRACORPOREAL CIRCULATION CANNULAE | C.R. Bard, Inc. | 1990-08-14 | Traditional | PDF ↗ |
| K901074 | CODE #94315 RETROGRADE CORONARY SINUS PERF CANNULA | Dlp, Inc. | 1990-07-06 | Traditional | PDF ↗ |
| K901231 | RMI CARDIOPLEGIA DELIVERY KITS | Research Medical, Inc. | 1990-06-08 | Traditional | PDF ↗ |
| K896338 | VOSS DISPOSABLE CORONARY BYPASS FLUSHING CANNULA | Voss Medical Products | 1990-05-17 | Traditional | PDF ↗ |
| K900753 | SHILEY VEIN IRRIGATION CANNULA (BEVELED & BLUNT) | Shiley, Inc. | 1990-04-10 | Traditional | PDF ↗ |
| K897022 | PICSO CANNULA, CATALOG CODE 94315 | Dlp, Inc. | 1990-03-16 | Traditional | PDF ↗ |
| K896778 | RMI VASOPLEGIA CANNULA WITH & WITHOUT CHECK VALVE | Research Medical, Inc. | 1990-02-27 | Traditional | PDF ↗ |
| K896777 | RMI AORTIC ROOT PRESSURE MONITOR EXTENSION LINE | Research Medical, Inc. | 1990-02-27 | Traditional | PDF ↗ |
| K897026 | CANYON MEDICAL FEMORAL BYPASS CANNULAE AND INTRO. | Canyon Medical Products | 1990-02-26 | Traditional | PDF ↗ |
| K896636 | RMI ANTEPLEGIA CANNULA | Research Medical, Inc. | 1990-02-15 | Traditional | PDF ↗ |
| K895352 | KENDALL INFANT ECMO VENOVENOUS CATHETER-DUAL LUMEN | Kendall Healthcare Products Co. Div.Of Tyco Health | 1989-11-29 | Traditional | PDF ↗ |
| K894684 | PTI INTRA-ART INTERNAL MAMMARY ARTERY CANNULA KIT | Pioneering Technologies, Inc. | 1989-10-17 | Traditional | PDF ↗ |
| K891576 | FEM-FLEX FEMORAL ACCESS CANNULATION SET | Research Medical, Inc. | 1989-10-12 | Traditional | PDF ↗ |
| K890980 | MODIFIED STOCKERT-SHILEY VENOUS CATHETER | Shiley, Inc. | 1989-05-01 | Traditional | PDF ↗ |
| K890024 | SARNS VENT CATHETER | 3M Company | 1989-03-02 | Traditional | PDF ↗ |
| K883412 | THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM) | Promedica Products, Inc. | 1989-02-08 | Traditional | PDF ↗ |
| K885188 | MODIFIED RT. ARTRIAL AND 13.5X11.5F CATH. TRAY | Quinton, Inc. | 1989-02-06 | Traditional | PDF ↗ |
| K884310 | ANGIOPUMP TUBING SET | Olympus Corp. | 1989-01-10 | Traditional | PDF ↗ |
| K884393 | MODIFIED SHILEY FEMORAL ARTERIAL CANNULA | Shiley, Inc. | 1988-12-27 | Traditional | PDF ↗ |
| K883981 | GUIDING CATHETER (TIP SOFTNESS CHANGE) | Devices For Vascular Intervention, Inc. | 1988-11-03 | Traditional | PDF ↗ |
| K883221 | PTI INTRA-ART INTER MAMM ARTERY PAPAVER INFUS KIT | Pioneering Technologies, Inc. | 1988-10-13 | Traditional | PDF ↗ |
| K882771 | EXTRACORPOREAL MEMBRANE OXYGENATION CATHETER | Cook, Inc. | 1988-09-27 | Traditional | PDF ↗ |
| K882034 | INTRA-ART(TM) INTERNAL MAMMARY INFUSION CATHETER | Buckman Co., Inc. | 1988-07-28 | Traditional | PDF ↗ |
| K881733 | SHILEY FEMORAL CORONARY PERFUSION CATHETER | Shiley, Inc. | 1988-07-06 | Traditional | PDF ↗ |
| K881691 | PREASSEMBLED SURGICAL WASH SET 122,175,225,375AA | Shiley, Inc. | 1988-07-05 | Traditional | PDF ↗ |
| K881734 | SHILEY FEMORAL LEFT VENTRICULAR VENT CATHETER | Shiley, Inc. | 1988-07-05 | Traditional | PDF ↗ |
| K881330 | COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK | Cobe Laboratories, Inc. | 1988-06-10 | Traditional | PDF ↗ |
| K881352 | RIGHT ATRIAL CATHETER INSERTION TRAY | Quinton, Inc. | 1988-06-09 | Traditional | PDF ↗ |
| K881072 | SHILEY FEMORAL ARTERIAL CANNULA | Shiley, Inc. | 1988-05-31 | Traditional | PDF ↗ |
| K881074 | SHILEY FEMORAL VENOUS CANNULA | Shiley, Inc. | 1988-05-31 | Traditional | PDF ↗ |
| K880887 | NEOCATH | Taris Corp. | 1988-05-24 | Traditional | PDF ↗ |
| K880777 | 8.5 FR. PESCUTANEOUS SHEATH INTRODUCER SYSTEM | Medsurg Industries, Inc. | 1988-05-24 | Traditional | PDF ↗ |
| K880779 | MEDSURG 16 GA. CENTRAL VEIN CATHETERIZATION TRAY | Medsurg Industries, Inc. | 1988-05-09 | Traditional | PDF ↗ |
| K880421 | DESCENDING ARCH CANNULA | Dlp, Inc. | 1988-04-28 | Traditional | PDF ↗ |
| K880103 | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPUL. | Research Medical, Inc. | 1988-03-22 | Traditional | PDF ↗ |
| K880180 | STATFLO | Imodex, Inc. | 1988-03-22 | Traditional | PDF ↗ |
| K875353 | PERCUTANEOUS ARTERIAL/VENOUS CANNULA PLACEMENT KIT | Dlp, Inc. | 1988-03-22 | Traditional | PDF ↗ |
| K874899 | CANYON MEDICAL FEMORAL BYPASS CANNULAE | Canyon Medical Products | 1988-02-18 | Traditional | PDF ↗ |
| K875048 | SARNS VENOATRIAL CATHETER | 3M Health Care, Sarns | 1988-02-18 | Traditional | PDF ↗ |
| K874852 | POLYSTAN WIRE REINFORCED TWO STAGE CATHETERS | Polystan C/O Vitalcor, Inc. | 1988-02-05 | Traditional | PDF ↗ |
| K874853 | POLYSTAN TWO STAGE CATHETERS | Polystan C/O Vitalcor, Inc. | 1988-02-05 | Traditional | PDF ↗ |
| K874896 | SARNS VISIFLOW AORTIC ARCH CANNULA | 3M Health Care, Sarns | 1988-02-02 | Traditional | PDF ↗ |
| K874834 | ARGYLE CARDIOPLEGIA CANNULA | Sherwood Medical Co. | 1988-01-19 | Traditional | PDF ↗ |
| K872033 | BIO-MEDICUS CANNULA-TUBING | Bio Medicus, Inc. | 1987-12-07 | Traditional | PDF ↗ |
| K873212 | SARNS CARDIOPLEGIA/VENT CATHETERS | 3M Health Care, Sarns | 1987-11-06 | Traditional | PDF ↗ |
Product code DWF · Class II · Cardiovascular. Data: openFDA.