FDA Product Code
FDA Product Code DTB — Clearance Directory
- Device Class
- Class III
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.3680
510(k) Clearances — 487 records · page 4 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K831997 | IMPLANTABLE ENDOCARDIAL PACING LEADS | Oscor, Inc. | 1983-10-20 | Traditional | PDF ↗ |
| K832987 | PERMANTHANE #866 BIPOLAR COAXIAL | Pacesetter Systems | 1983-10-20 | Traditional | PDF ↗ |
| K833099 | BIOTRONIK N, BIPOLAR PEB-60/4-N | Biotronik Sales, Inc. | 1983-10-20 | Traditional | PDF ↗ |
| K833098 | BIOTRONIK DN UNIPOLAR PE-60/4-DN & | Biotronik Sales, Inc. | 1983-10-19 | Traditional | PDF ↗ |
| K833108 | BIOTRONIK I-UNIPOLAR PE-60/2-13 | Biotronik Sales, Inc. | 1983-10-19 | Traditional | PDF ↗ |
| K833101 | BIOTRONIK DYC, UNIPOLAR PE-60/4-DYC | Biotronik Sales, Inc. | 1983-10-19 | Traditional | PDF ↗ |
| K833104 | BIOTRONIK D2K UNIPOLAR PE-60/4 | Biotronik Sales, Inc. | 1983-10-19 | Traditional | PDF ↗ |
| K832409 | LIFELINE PACING LEADS #471-07 &09 | Intermedics, Inc. | 1983-08-12 | Traditional | PDF ↗ |
| K832255 | MODEL F UNIPOLAR ENDOCARDIAL LEAD- | Cook Pacemaker Corp. | 1983-08-12 | Traditional | PDF ↗ |
| K832245 | UNIPOLAR-E ENDOCARDIAL TINED LEAD | Cook Pacemaker Corp. | 1983-08-12 | Traditional | PDF ↗ |
| K832110 | ELECTRODE LEADS 030-267 & 030-268 | Telectronics, Inc. | 1983-08-12 | Traditional | PDF ↗ |
| K831767 | IMPLANTABLE CARDIAC PACING LEADS | Oscor, Inc. | 1983-07-26 | Traditional | PDF ↗ |
| K832099 | MEDTRONIC MODELS 4012 & 4512 | Medtronic Vascular | 1983-07-26 | Traditional | PDF ↗ |
| K831529 | CCS MODEL SJ-103 IMPLANTABLE ATRIAL | Cardiac Control Systems, Inc. | 1983-06-30 | Traditional | PDF ↗ |
| K831436 | UNIPOLAR ATRIAL J PACING LEAD MODEL 869 | Pacesetter Systems | 1983-06-08 | Traditional | PDF ↗ |
| K831435 | VENTRICULAR PACING LEADS MODELS 865/867 | Pacesetter Systems | 1983-06-08 | Traditional | PDF ↗ |
| K831303 | TELECTRONICS #030-253 BIFURCATED | William C. Nealon | 1983-05-25 | Traditional | PDF ↗ |
| K830743 | POROUS TIP ENDOCARDIAL LEAD | Daig Corp. | 1983-05-09 | Traditional | PDF ↗ |
| K823892 | MODEL SZ PACEMAKER LEAD-VARIOUS | Dr. Ing. P. Osypka, GmbH | 1983-04-30 | Traditional | PDF ↗ |
| K823895 | MODEL RF. D&RX..D PACEMAKER LEADS | Oscor, Inc. | 1983-04-30 | Traditional | PDF ↗ |
| K823898 | MODEL MF..D & MX..D PACEMAKER LEADS | Oscor, Inc. | 1983-04-30 | Traditional | PDF ↗ |
| K823896 | MODEL FF..D & FX..D PACEMAKER LEADS | Dr. Ing. P. Osypka, GmbH | 1983-04-30 | Traditional | PDF ↗ |
| K823894 | MODEL RZ PACEMAKER LEAD VARIOUS | Dr. Ing. P. Osypka, GmbH | 1983-04-30 | Traditional | PDF ↗ |
| K823889 | MODEL JY PACEMAKER LEAD - VARIOUS | Oscor, Inc. | 1983-04-30 | Traditional | PDF ↗ |
| K823897 | MODEL SF. D&SX.D PACEMAKER LEADS | Oscor, Inc. | 1983-04-30 | Traditional | PDF ↗ |
| K823893 | MODEL MZ PACEMAKER LEAD-VARIOUS | Oscor, Inc. | 1983-04-30 | Traditional | PDF ↗ |
| K830828 | IMPLANTABLE PACING LEAD CCS MODEL SV-101 | Cardiac Control Systems, Inc. | 1983-04-28 | Traditional | PDF ↗ |
| K830950 | VASCULAR PRODUCTS IMPLANTABLE PACING | Oscor, Inc. | 1983-04-18 | Traditional | PDF ↗ |
| K830782 | LIFELINE ENDOCARDIAL PACING LEAD #479-05 | Intermedics, Inc. | 1983-04-18 | Traditional | PDF ↗ |
| K823890 | MODEL ZY PACEMAKER LEAD-VARIOUS | Oscor, Inc. | 1983-03-31 | Traditional | PDF ↗ |
| K823891 | MODEL KY PACEMAKER LEAD - VARIOUS | Oscor, Inc. | 1983-03-31 | Traditional | PDF ↗ |
| K830457 | PACING LEAD #PMA F 860 | Ela Medical, Inc. | 1983-03-17 | Traditional | PDF ↗ |
| K830464 | PACEMAKER ELECTRODE PERM. & TEMP | Daig Corp. | 1983-03-16 | Traditional | PDF ↗ |
| K830463 | LIFELINE UNIPOLAR J-LEAD #483-05 | Intermedics, Inc. | 1983-02-28 | Traditional | PDF ↗ |
| K823508 | LIFELINE -UNIPOLAR LEAD #487-05 | Intermedics, Inc. | 1983-01-14 | Traditional | PDF ↗ |
| K823452 | ELECTRODE LEAD OF SILICONE ELASTOMETER | Telectronics, Inc. | 1983-01-08 | Traditional | PDF ↗ |
| K823033 | ELECTRODE, PACEMAKER, PERMANENT | Pacesetter Systems | 1982-12-30 | Traditional | PDF ↗ |
| K823448 | IMPLANTABLE PACING LEAD TINED #3390 & | Oscor, Inc. | 1982-12-03 | Traditional | PDF ↗ |
| K823446 | PRODUCTS IMPLANTABLE PACING LEAD,TINED | Oscor, Inc. | 1982-12-03 | Traditional | PDF ↗ |
| K823447 | IMPLANTABLE PACING LEAD, TINED #3262 & | Vascular Products, Inc. | 1982-12-03 | Traditional | PDF ↗ |
| K822781 | MEDTRONIC MODELS 4011 & 4511 | Medtronic Vascular | 1982-11-30 | Traditional | PDF ↗ |
| K822239 | COAXIAL BIPOLAR PACING ELECTRODE | Burditt & Calkins-Siemens-Elema | 1982-10-04 | Traditional | PDF ↗ |
| K820989 | MEDTRONIC #6993 | Medtronic Vascular | 1982-08-06 | Traditional | PDF ↗ |
| K821889 | POROUS SURFACED PLATINUM IRIDIUM | Cordis Corp. | 1982-08-06 | Traditional | PDF ↗ |
| K821947 | FASTPASS IMPLANTABLE ENDOCARD. PACING | Pacesetter Systems | 1982-08-06 | Traditional | PDF ↗ |
| K820487 | IMPLANTIBLE SUTURE SLEEVE | Intermedics, Inc. | 1982-04-16 | Traditional | PDF ↗ |
| K820767 | BIOPOLAR TINED ENDOCARDIAL LEAD 403B/60 | Siemens Elema AB | 1982-04-09 | Traditional | PDF ↗ |
| K812049 | STOCKERT CARDIAC PACING ELECTRODES | Stoeckert Instrumente | 1982-03-18 | Traditional | PDF ↗ |
| K820262 | PERMANENT & TEMPORARY PACEMAKER ELECTR. | Diag Corp. | 1982-03-12 | Traditional | PDF ↗ |
| K820121 | LASERPOR AP ATRIAL ENDOCARD. ELECTR. LD. | Telectronics, Inc. | 1982-02-12 | Traditional | PDF ↗ |
| K812905 | PERMANENT ENDOCARD. UNIPOLAR TINED LEAD | Diag Corp. | 1982-02-04 | Traditional | PDF ↗ |
| K813205 | INTERSEPT CARDIOTOMY RESERVOIR/FILTER | Extracorporeal Medical Specialities, Inc. | 1982-01-28 | Traditional | PDF ↗ |
| K812807 | APC IMPLANTABLE PACING LEADS | American Pacemaker Corp. | 1982-01-18 | Traditional | PDF ↗ |
| K812830 | APC IMPLANTABLE PACING LEAD | American Pacemaker Corp. | 1982-01-18 | Traditional | PDF ↗ |
| K813134 | ATRIAL ENDOCARDIAL ELECTRODE LEAD J-TIP | Telectronics, Inc. | 1981-12-10 | Traditional | PDF ↗ |
| K813028 | POLY-FLEX PACING LEADS | Intermedics, Inc. | 1981-12-10 | Traditional | PDF ↗ |
| K810286 | PACEPATH IMPLANT. ENDOCARD. PACING LEAD | Pacesetter Systems | 1981-11-27 | Traditional | PDF ↗ |
| K810139 | ELECTRODE, PACEMAKER, PERMANENT | Pacesetter Systems | 1981-11-27 | Traditional | PDF ↗ |
| K812990 | INTERMEDICS POLYFLEX-MODEL 483-03 LEAD | Intermedics, Inc. | 1981-11-16 | Traditional | PDF ↗ |
| K812991 | INTERMEDICS POLYFLEX-MODEL 483-04 LEAD | Intermedics, Inc. | 1981-11-16 | Traditional | PDF ↗ |
| K812989 | INTERMEDICS POLYFLEX-MODEL 493-03 LEAD | Intermedics, Inc. | 1981-11-16 | Traditional | PDF ↗ |
| K812815 | MODEL 833 ENDOCARDIAL TINED LEAD | Pacesetter Systems | 1981-10-29 | Traditional | PDF ↗ |
| K812816 | MODEL 841 ENDOCARDIAL TINED LEAD | Pacesetter Systems | 1981-10-29 | Traditional | PDF ↗ |
| K812599 | MEDTRONIC #4951 | Medtronic Vascular | 1981-10-23 | Traditional | PDF ↗ |
| K811593 | ATRIAL ENDOCARDIAL ELECTRODE LEAD OF J | Telectronics, Inc. | 1981-10-13 | Traditional | PDF ↗ |
| K812245 | INTERMEDICS POLY FLEX ENDOCARDIAL ATRIAL | Intermedics, Inc. | 1981-10-06 | Traditional | PDF ↗ |
| K812221 | INTERMEDICS POLY FLEX EPICARDIAL SUTURE | Intermedics, Inc. | 1981-10-06 | Traditional | PDF ↗ |
| K812270 | PERM. ENDOCARDIAL UNIPOLAR TINED ATRIAL | Diag Corp. | 1981-09-16 | Traditional | PDF ↗ |
| K811200 | PACEPATH IMPLANTABLE ENDOCARD. PACING LD | Pacesetter Systems | 1981-08-13 | Traditional | PDF ↗ |
| K810494 | TYPE FH ENDOCARDIAL LEAD | Biotronik Sales, Inc. | 1981-08-07 | Traditional | PDF ↗ |
| K811877 | MODEL C UNIPOLAR ENDOCARDIAL LEAD | Cook Pacemaker Corp. | 1981-08-03 | Traditional | PDF ↗ |
| K811878 | MODEL B BIPOLAR ENDOCARDIAL LEAD | Cook Pacemaker Corp. | 1981-08-03 | Traditional | PDF ↗ |
| K811876 | MODEL D BIPOLAR ENDOCARDIAL LEAD | Cook Pacemaker Corp. | 1981-08-03 | Traditional | PDF ↗ |
| K811879 | MODEL A UNIPOLAR ENDOCARDIAL LEAD | Cook Pacemaker Corp. | 1981-08-03 | Traditional | PDF ↗ |
| K810928 | ENDOCARDIAL ELECTRODE | Vitatron Medical BV | 1981-07-02 | Traditional | PDF ↗ |
| K811539 | CORDIS ENCOR PEWENOUS VENTRICULAR BIPOL | Cordis Corp. | 1981-07-01 | Traditional | PDF ↗ |
| K811106 | INTERMEDICS POLY FLEX ENDOCARDIAL PACING | Intermedics, Inc. | 1981-05-27 | Traditional | PDF ↗ |
| K810397 | APC IMPLANTABLE PACING LEAD-FLANGE #3260 | American Pacemaker Corp. | 1981-05-15 | Traditional | PDF ↗ |
| K810398 | APC IMPLANTABLE PACING LEAD, MODEL 3266 | American Pacemaker Corp. | 1981-05-15 | Traditional | PDF ↗ |
| K810399 | APC IMPLANTABEL PACING LEAD, MODEL 3264 | American Pacemaker Corp. | 1981-05-15 | Traditional | PDF ↗ |
| K810396 | APC IMPLANTABLE PACING LEAD, TINED #3262 | American Pacemaker Corp. | 1981-05-15 | Traditional | PDF ↗ |
| K810493 | TYPE N ENDOCARDIAL LEAD | Biotronik Sales, Inc. | 1981-03-20 | Traditional | PDF ↗ |
| K810491 | TYPE YC ENDOCARDIAL LEAD | Biotronik Sales, Inc. | 1981-03-20 | Traditional | PDF ↗ |
| K810492 | TYPE YR ENDOCARDIAL LEAD | Biotronik Sales, Inc. | 1981-03-20 | Traditional | PDF ↗ |
| K810582 | ELECTRODE, PACEMAKER PERMANENT | Pacesetter Systems | 1981-03-13 | Traditional | PDF ↗ |
| K810432 | CORDIS PERVENOUS ATRIAL LEAD | Cordis Corp. | 1981-03-13 | Traditional | PDF ↗ |
| K810333 | TEMPORARY MYOCARDIAL PACING LEAD#6400 | Medtronic Vascular | 1981-03-13 | Traditional | PDF ↗ |
| K802295 | POLY FLEX IMPLANTABLE PACING LEAD | Intermedics, Inc. | 1981-02-09 | Traditional | PDF ↗ |
| K810202 | CORDIS MULTIFILAR PERVENOUS VENTRIC. LD | Cordis Corp. | 1981-02-05 | Traditional | PDF ↗ |
| K802816 | ENDOCARDIAL LEADS 414S & 515S | Siemens Elema AB | 1981-01-16 | Traditional | PDF ↗ |
| K802547 | PERMANENT & TEMP. PACEMAKER ELECTRODE | Daig Corp. | 1981-01-16 | Traditional | PDF ↗ |
| K802552 | PERM. ENDOCARDIAL UNIPOLAR TINED/WEDGE | Daig Corp. | 1981-01-16 | Traditional | PDF ↗ |
| K802553 | PERM. ENDOCARDIAL UNIPOLAR WEDGE URETHAN | Daig Corp. | 1981-01-16 | Traditional | PDF ↗ |
| K802413 | IMPLANT. ENDOCARDIAL DISH TIP ELECT. LDS | Telectronics, Inc. | 1981-01-02 | Traditional | PDF ↗ |
| K803042 | SIEMENS-ELEMA ENDOCARDIAL LEAD 402S | Siemens Elema AB | 1980-12-22 | Traditional | PDF ↗ |
| K802968 | UNIPOLAR ENDOCARDIAL LASER DRILLED ELEC | Telectronics, Inc. | 1980-12-22 | Traditional | PDF ↗ |
| K801172 | INTERMEDICS' LIFELINE TLE ENDOCARDIAL | Intermedics, Inc. | 1980-12-01 | Traditional | PDF ↗ |
| K801284 | LOW PROFILE LEAD CONNECTOR MODIFICATION (4002) | Medtronic Vascular | 1980-12-01 | Traditional | PDF ↗ |
| K800870 | MEDTRONIC MODEL 6958 | Medtronic Vascular | 1980-11-13 | Traditional | PDF ↗ |
| K801416 | PACEPATH MODEL 810 | Pacesetter Systems | 1980-10-31 | Traditional | PDF ↗ |
Product code DTB · Class III · Cardiovascular. Data: openFDA.