FDA Product Code
FDA Product Code DSY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.3450
510(k) Clearances — 188 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K961134 | BARD GRAFT SIZER | C.R. Bard, Inc. | 1996-06-19 | Traditional | PDF ↗ |
| K955460 | MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFT | Meadox Medicals, Div. Boston Scientific Corp. | 1996-05-30 | Traditional | PDF ↗ |
| K960706 | VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT | Carbomedics, Inc. | 1996-04-25 | Traditional | PDF ↗ |
| K955532 | DIASTAT VASCULAR ACCESS GRAFT | W. L. Gore & Associates, Inc. | 1996-03-11 | Traditional | PDF ↗ |
| K955588 | VASCUTEK GRAFT SIZER SET | Carbomedics, Inc. | 1996-03-07 | Traditional | PDF ↗ |
| K955230 | VASCUTEK GELSOFT PLUS VASCULAR GRAFT | Vascutek, Ltd. | 1996-02-09 | Traditional | PDF ↗ |
| K952293 | VASCUTEK GELWEAVE VASCULAR GRAFT | Vascutek, Ltd. | 1995-12-19 | Traditional | PDF ↗ |
| K954582 | BARD EXPANDED PTFE VASCULAR GRAFT(MODIFICATION) | C.R. Bard, Inc. | 1995-12-07 | Traditional | PDF ↗ |
| K953288 | DIASTAT VASCULAR ACCESS GRAFT | W. L. Gore & Associates, Inc. | 1995-10-06 | Traditional | PDF ↗ |
| K944858 | BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS | Baxter Edwards | 1995-01-05 | Traditional | PDF ↗ |
| K941981 | AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED | W. L. Gore & Associates, Inc. | 1994-07-20 | Traditional | PDF ↗ |
| K940816 | BARD(R) EXPANDED PTFE VASCULAR GRAFT | C.R. Bard, Inc. | 1994-06-02 | Traditional | PDF ↗ |
| K933987 | AOR-TEX VASCULAR GRAFT | W. L. Gore & Associates, Inc. | 1994-05-17 | Traditional | PDF ↗ |
| K940062 | DIASTAT VASCULAR ACCESS GRAFT | W. L. Gore & Associates, Inc. | 1994-05-02 | Traditional | PDF ↗ |
| K933590 | BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT | Baxter Healthcare Corp | 1994-01-26 | Traditional | PDF ↗ |
| K933943 | FEP RINGED GORE-TEX STRETCH VASCUALR GRAFT WITH REMOVABLE RINGS | W. L. Gore & Associates, Inc. | 1993-12-08 | Traditional | PDF ↗ |
| K933204 | BARD PTFE VASCULAR GRAFT | C.R. Bard, Inc. | 1993-10-27 | Traditional | PDF ↗ |
| K925123 | ATRIUM'S HYBRID PTFE | Atrium Medical Corp. | 1993-05-27 | Traditional | PDF ↗ |
| K922905 | FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT | W. L. Gore & Associates, Inc. | 1992-11-24 | Traditional | PDF ↗ |
| K922025 | ANASTOMART(TM) CORONARY BYPASS GRAFT MARKERS/MODIF | Pioneering Technologies, Inc. | 1992-09-22 | Traditional | PDF ↗ |
| K914116 | PLASMA TFE SYNTHETIC ARTERY-CLARIFICATION | Medtronic Vascular | 1991-11-27 | Traditional | PDF ↗ |
| K914447 | GORE-TEX(R) VASCULAR GRAFTS, PROCESS CHANGE | W. L. Gore & Associates, Inc. | 1991-11-05 | Traditional | PDF ↗ |
| K913143 | OCHSNER ULP BIFURCATION VASCULAR PROTHESIS | Intervascular, Inc. | 1991-10-23 | Traditional | PDF ↗ |
| K912911 | LOW POROSITY (LP) VASCULAR PROSTHESIS | Intervascular, Inc. | 1991-09-23 | Traditional | PDF ↗ |
| K905269 | OCHSNER 500 VASCULAR PROSTHESIS | Intervascular, Inc. | 1991-04-02 | Traditional | PDF ↗ |
| K910864 | EXTERNALLY REINFORCED TRIAXIAL PROSTHESIS | Vascutek, Ltd. | 1991-04-01 | Traditional | PDF ↗ |
| K910863 | EXTRA SOFT/EXTRA LOW WOVEN VASCULAR PROTHESIS | Vascutek, Ltd. | 1991-04-01 | Traditional | PDF ↗ |
| K910865 | TRIAXIL (VP50K) KNITTED VASCULAR PROSTHESIS | Vascutek, Ltd. | 1991-04-01 | Traditional | PDF ↗ |
| K910866 | VASCUSOFT (VP1200K) KNITTED VASCULAR PROSTHESIS | Vascutek, Ltd. | 1991-04-01 | Traditional | PDF ↗ |
| K905067 | PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT | Pioneering Technologies, Inc. | 1991-03-18 | Traditional | PDF ↗ |
| K905270 | OCHSNER 50 VASCULAR PROSTHESIS | Intervascular, Inc. | 1991-02-15 | Traditional | PDF ↗ |
| K904282 | BIFURCATED GORE TEX STRETCH VASCULAR GRAFT | W. L. Gore & Associates, Inc. | 1991-01-16 | Traditional | PDF ↗ |
| K903931 | GORE-TEX(R) STRETCH VASCULAR GRAFT | W. L. Gore & Associates, Inc. | 1990-12-06 | Traditional | PDF ↗ |
| K903964 | OCHSNER 50 BIFURCATION | Intervascular, Inc. | 1990-12-03 | Traditional | PDF ↗ |
| K901641 | AXILLOBIFEMORAL GORE-TEX VASCULAR GRAFT | W. L. Gore & Associates, Inc. | 1990-09-05 | Traditional | PDF ↗ |
| K901682 | PTI ANASTOMARK(TM) CORONARY BYPASS GRAFT MARKERS | Pioneering Technologies, Inc. | 1990-07-03 | Traditional | PDF ↗ |
| K896964 | PLASMA TFE VASCULAR PROSTHESIS MODIFIED INSTRUC. | Medtronic Vascular | 1990-06-21 | Traditional | PDF ↗ |
| K890182 | PROTEGRAFT DV 1500, 1900 & LOW POR, UNIGRAFT DV | Aesculap Instruments Corp. | 1990-02-28 | Traditional | PDF ↗ |
| K894732 | VASCULAR GRAFT PACKAGE (SHELF-LIFE EXTENSION) | Medtronic Vascular | 1989-10-12 | Traditional | PDF ↗ |
| K890597 | EXTENDED PACKAGE DATING ON VELEX WOVEN GRAFTS | D-R Medical Systems, Inc. | 1989-09-26 | Traditional | PDF ↗ |
| K893459 | PLASMA TFE VASCULAR PROSTHESIS (ALTER. PACKAGE) | Medtronic Vascular | 1989-09-20 | Traditional | PDF ↗ |
| K884083 | TORAY VASCULAR PROSTHESIS | Toray Industries (America), Inc. | 1989-01-12 | Traditional | PDF ↗ |
| K882289 | ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH. | Aries Medical, Inc. | 1988-12-12 | Traditional | PDF ↗ |
| K882314 | CORONARY VEIN GRAFT MARKER | Med-Edge, Inc. | 1988-08-04 | Traditional | PDF ↗ |
| K880041 | VELEX WOVEN DACRON LOW PORSITY VASCULAR GRAFT | D-R Medical Systems, Inc. | 1988-06-10 | Traditional | PDF ↗ |
| K880040 | VELEX WOVEN EXTERNAL VELOUR DACRON GRAFT | D-R Medical Systems, Inc. | 1988-06-09 | Traditional | PDF ↗ |
| K881283 | MEADOX INTRA-AORTIC GRAFT | Meadox Medicals, Div. Boston Scientific Corp. | 1988-05-26 | Traditional | PDF ↗ |
| K880167 | GORE-TEX VASCULAR GRAFT | W. L. Gore & Associates, Inc. | 1988-05-18 | Traditional | PDF ↗ |
| K870884 | RADIALLY-SUPPORTED VASCULAR PROSTHESES | Intervascular, Inc. | 1988-02-05 | Traditional | PDF ↗ |
| K871110 | CORONARY ARTERY BYPASS GRAFT (CABG) MARKER | Edward Weck, Inc. | 1987-08-27 | Traditional | PDF ↗ |
| K862697 | AVTECH LWP*(LOW POROSITY) MWP*(MEDIUM POROSITY) | Advanced Vascular Technologies, Inc. | 1986-12-05 | Traditional | PDF ↗ |
| K861808 | VASCUTEK VASCULAR PROSTHESES, EXTRA SOFT/LOW WOVEN | Cobe Laboratories, Inc. | 1986-09-15 | Traditional | PDF ↗ |
| K862739 | INTERVASCULAR OCHSNER MICRON VASCULAR PROSTHESES | Intervascular, Inc. | 1986-08-21 | Traditional | PDF ↗ |
| K854845 | INTERVASCULAROCHSNER 50 AND OCHSNER 500 VASCULAR | Intervascular, Inc. | 1986-08-18 | Traditional | PDF ↗ |
| K841596 | MEADOS INTRAORTIC GRAFT | Meadox Medicals, Div. Boston Scientific Corp. | 1986-05-08 | Traditional | PDF ↗ |
| K854431 | MEADOX MEDICALS INC. GRAFT SIZER | Meadox Medicals, Div. Boston Scientific Corp. | 1986-05-07 | Traditional | PDF ↗ |
| K853101 | VASCUTER EXTERNAL REINFORCE TRIAXIAL PROSTHESES | Cobe Laboratories, Inc. | 1986-02-24 | Traditional | PDF ↗ |
| K853725 | ATRIUM PLASMA TFE SYNTHETIC ARTERY | Atrium Medical Corp. | 1985-12-09 | Traditional | PDF ↗ |
| K831822 | TETRAFLEX INTEGRALLY SUPPORTED PTFE | Shiley, Inc. | 1984-10-16 | Traditional | PDF ↗ |
| K833716 | LP200 & HP800 SERIES VASCULAR PROSTH | Intervascular, Inc. | 1984-01-10 | Traditional | PDF ↗ |
| K830016 | VASCUTEK VASCULAR PROTHESIS VP1200K/50K | Pacesetter Systems | 1983-12-21 | Traditional | PDF ↗ |
| K831865 | IONESCU-SHILEY LOW POROSITY COMPOSITE | Shiley, Inc. | 1983-10-19 | Traditional | PDF ↗ |
| K831880 | IONESCU-SHILEY LOW POROSITY AORTIC GRAFT | Shiley, Inc. | 1983-10-19 | Traditional | PDF ↗ |
| K832806 | CORONARY ANASTOMOSIS MARKING SYSTEM | Biotrac Laboratories | 1983-09-29 | Traditional | PDF ↗ |
| K830543 | VASCULAR GRAFT PROSTHESIS EXPANDED MICR | Impra, Inc. | 1983-07-19 | Traditional | PDF ↗ |
| K822633 | MICROVEL DOUBLE VELOUR SUPPORTED 100 | Meadox Medicals, Div. Boston Scientific Corp. | 1983-07-12 | Traditional | PDF ↗ |
| K821716 | BARD PTFE VASCULAR PROSTHESIS | C.R. Bard, Inc. | 1982-08-31 | Traditional | PDF ↗ |
| K820696 | MEADOX WOVEN DOUBLE VELOUR | Meadox Medicals, Div. Boston Scientific Corp. | 1982-07-09 | Traditional | PDF ↗ |
| K820600 | HANCOCK VASCULAR GRAFT | Extracorporeal Medical Specialities, Inc. | 1982-07-08 | Traditional | PDF ↗ |
| K821158 | FED RINGED-TEX VASCULAR GRAFT | W. L. Gore & Associates, Inc. | 1982-05-18 | Traditional | PDF ↗ |
| K812248 | COOLEY 2 VASCULAR PROSTHESIS STRAIGHT | Meadox Medicals, Div. Boston Scientific Corp. | 1981-11-24 | Traditional | PDF ↗ |
| K811441 | MANUFACTURING PROCESS CHANGE | Meadox Medicals, Div. Boston Scientific Corp. | 1981-09-16 | Traditional | PDF ↗ |
| K811510 | GORE-TEX VASULAR GRAFT | W. L. Gore & Associates, Inc. | 1981-08-20 | Traditional | PDF ↗ |
| K810845 | DOUBLE VELOUR GRAFTS | Meadox Medicals, Div. Boston Scientific Corp. | 1981-05-08 | Traditional | PDF ↗ |
| K810376 | MEADOX SZILAGYI GRAFT | Meadox Medicals, Div. Boston Scientific Corp. | 1981-03-05 | Traditional | PDF ↗ |
| K803000 | IONESCU-SHILEY AORTIC GRAFT VALVE | Shiley, Inc. | 1981-02-02 | Traditional | PDF ↗ |
| K802095 | GORE-TEX VASCULAR GRAFT | W. L. Gore & Associates, Inc. | 1980-10-10 | Traditional | PDF ↗ |
| K801621 | VASCULAR GRAFT PROSTH. OF EXP. MICRO. | Impra, Inc. | 1980-09-09 | Traditional | PDF ↗ |
| K801156 | USCI INTRALUMINAL GRAFT W/DACRON TIE | C.R. Bard, Inc. | 1980-05-23 | Traditional | PDF ↗ |
| K800149 | USCI SAUVAGE EXS VASCULAR PROSTHESIS | C.R. Bard, Inc. | 1980-02-28 | Traditional | PDF ↗ |
| K791828 | BJORK-SHILEY PULMONIC GRAFT VALVE | Shiley, Inc. | 1979-09-27 | Traditional | PDF ↗ |
| K771819 | CABG RINGS | A&A Ent. | 1977-10-21 | Traditional | PDF ↗ |
| K770236 | SAUVAGE FILAMENTOUS PROSTHESES | Usci, Div. C.R. Bard, Inc. | 1977-02-25 | Traditional | PDF ↗ |
| K770235 | DEBAKEY VASCULOUR-D PROSTHESES | Usci, Div. C.R. Bard, Inc. | 1977-02-24 | Traditional | PDF ↗ |
| K760090 | GRAFT, COOLEY GUIDELINE, STERILE | Meadox Medicals, Div. Boston Scientific Corp. | 1976-07-20 | Traditional | PDF ↗ |
| K760130 | PROSTHESIS, VASCULAR BIFURCATED | Usci, Div. C.R. Bard, Inc. | 1976-07-20 | Traditional | PDF ↗ |
| K760091 | GRAFT, MICROVEL GUIDELINE, STERILE | Meadox Medicals, Div. Boston Scientific Corp. | 1976-07-20 | Traditional | PDF ↗ |
| K760092 | GRAFT, COOLEY WOVEN VASCULAR, STERILE | Meadox Medicals, Div. Boston Scientific Corp. | 1976-07-20 | Traditional | PDF ↗ |
Product code DSY · Class II · Cardiovascular. Data: openFDA.