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 5 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K802293 | POLYFLEX IMPLANTABLE PACING LEAD | Intermedics, Inc. | 1980-10-31 | Traditional | PDF ↗ |
| K801792 | IMPLANTABLE ENDOCARDIAL POROUS TIP ELEC. | Telectronics, Inc. | 1980-10-23 | Traditional | PDF ↗ |
| K801455 | LEAD, ENDOCARDIAL, TINED, BIPOLAR, 5MM | Pacesetter Systems | 1980-10-23 | Traditional | PDF ↗ |
| K801417 | PACEPATH MODEL 819 | Pacesetter Systems | 1980-10-23 | Traditional | PDF ↗ |
| K800944 | MEDTRONIC MODEL 69575 | Medtronic Vascular | 1980-09-26 | Traditional | PDF ↗ |
| K800795 | PERMANENT & TEMP. PACEMAKER ELECTRODE | Daig Corp. | 1980-06-30 | Traditional | PDF ↗ |
| K792301 | LIFELINE TLE J-SHAPED ATRIAL ENDOCARDIAL | Intermedics, Inc. | 1980-06-04 | Traditional | PDF ↗ |
| K792300 | LIFELINE TLE (TRAEBECULAR LODGING ELEC | Intermedics, Inc. | 1980-06-04 | Traditional | PDF ↗ |
| K800354 | LEAD, TINED PACING, IMPLANTABLE | Daig Corp. | 1980-05-30 | Traditional | PDF ↗ |
| K800350 | ENDOCARD. PACING LEAD STD. LENGTH PL202 | Daig Corp. | 1980-05-28 | Traditional | PDF ↗ |
| K800351 | PACEMAKER, ELECTRODE, PERM. & TEMP. | Daig Corp. | 1980-05-28 | Traditional | PDF ↗ |
| K800347 | PERM. INPLANT ENDOCARD. PAC. LEAD | Daig Corp. | 1980-05-28 | Traditional | PDF ↗ |
| K800349 | ENDOCARD. PACING LEAD LONG LENGTH PL200 | Diag Corp. | 1980-05-28 | Traditional | PDF ↗ |
| K800352 | PACEMAKER, ELECTRODE | Daig Corp. | 1980-05-28 | Traditional | PDF ↗ |
| K800348 | UNIPOLAR LEAD CONFIGURATION CONDUCTOR | Daig Corp. | 1980-05-28 | Traditional | PDF ↗ |
| K800891 | RESTERILIZATION OF IMPLANTABLE ELECTRODE | Telectronics, Inc. | 1980-05-28 | Traditional | PDF ↗ |
| K800355 | LEAD, SUTURELESS MYOCARDIAL | Daig Corp. | 1980-05-28 | Traditional | PDF ↗ |
| K792604 | LIFELINE TLE ENDOCARDIAL PACING LEAD, | Intermedics, Inc. | 1979-12-31 | Traditional | PDF ↗ |
| K792321 | IMPLANTABLE END. MUSH. TIP LEADS030-224 | Telectronics, Inc. | 1979-12-13 | Traditional | PDF ↗ |
| K792379 | CARDIAC PACING ELECTRODE | Medi-Dyne Instruments, Inc. | 1979-12-05 | Traditional | PDF ↗ |
| K792387 | IMPLANTABLE ENDOCARDIAL TINED ELECTRODE | Telectronics, Inc. | 1979-12-05 | Traditional | PDF ↗ |
| K792168 | LIFELINE - ENDOCARDIAL PACING LEAD | Intermedics, Inc. | 1979-11-13 | Traditional | PDF ↗ |
| K791768 | CORDIS PERMANENT PERVENOUS CARDIAC LEADS | Cordis Corp. | 1979-11-05 | Traditional | PDF ↗ |
| K791769 | MEDTRONIC MODEL 6957 | Medtronic Vascular | 1979-09-19 | Traditional | PDF ↗ |
| K791732 | IMPLANTABLE ENDOCARDIAL SCREW-IN ELEC | Oscor, Inc. | 1979-09-19 | Traditional | PDF ↗ |
| K790143 | VENTRICULAR LEAD, MODEL 6959 | Medtronic Vascular | 1979-09-19 | Traditional | PDF ↗ |
| K791378 | MODEL 482-01 BIPOLAR COAXIAL PACING LEAD | Intermedics, Inc. | 1979-09-12 | Traditional | PDF ↗ |
| K791377 | MODEL 484-01 BIPOLAR COAXIAL PACING LEAD | Intermedics, Inc. | 1979-09-12 | Traditional | PDF ↗ |
| K791667 | MEDTRONIC MODELS 69914/699OU | Medtronic Vascular | 1979-09-07 | Traditional | PDF ↗ |
| K791552 | MODELS UL-804 AND BL-801 UNIPOLAR LEADS | Pacesetter Systems | 1979-09-04 | Traditional | PDF ↗ |
| K790983 | BIFLEX TM TEMPORARY PACING PROBE | Advanced Medical Concepts, Inc. | 1979-07-10 | Traditional | PDF ↗ |
| K790429 | MEDTRONIC MODEL 6957 | Medtronic Vascular | 1979-07-05 | Traditional | PDF ↗ |
| K790988 | MODEL 6971 W/ DBS WIRE | Medtronic Vascular | 1979-06-11 | Traditional | PDF ↗ |
| K782018 | LEADS, IMPLANTABLE CARDIAC PACEMAKERS | Oscor, Inc. | 1979-06-04 | Traditional | PDF ↗ |
| K790548 | ENDOCARDIAL PACING LEAD, MODEL 476-01 | Intermedics, Inc. | 1979-06-01 | Traditional | PDF ↗ |
| K790766 | MEDTRONIC MODELS 6907/6901 | Medtronic Vascular | 1979-05-25 | Traditional | PDF ↗ |
| K790344 | BIPOLAR PERNENOUS VENTRICULAR LEAD | Cordis Corp. | 1979-04-17 | Traditional | PDF ↗ |
| K790462 | MEDTRONIC MODEL 6972 | Medtronic Vascular | 1979-04-16 | Traditional | PDF ↗ |
| K790386 | LEAD MODELS MUM 1260, MUM 1290 | Ela Medical, Inc. | 1979-04-03 | Traditional | PDF ↗ |
| K790074 | MEDTRONIC MODEL 6971 | Medtronic Vascular | 1979-03-29 | Traditional | PDF ↗ |
| K790261 | MEDTRONIC TEMPTRON | Medtronic Vascular | 1979-02-27 | Traditional | PDF ↗ |
| K790116 | CARDIOTOMY RESERVOIR CR-2000 | Delta Medical Industries | 1979-02-08 | Traditional | PDF ↗ |
| K781497 | LIFELINE PACING LEAD MODEL 465-01 | Intermedics, Inc. | 1979-02-01 | Traditional | PDF ↗ |
| K781570 | SUTURELESS MUOCARDINE PACING LEADS 471 | Intermedics, Inc. | 1979-02-01 | Traditional | PDF ↗ |
| K781525 | ENDOCARIDAL PACING LEAD UNIPOLAR 477 | Intermedics, Inc. | 1979-02-01 | Traditional | PDF ↗ |
| K781499 | LIFELINE PACING LEAD MODEL 467-01 | Intermedics, Inc. | 1979-02-01 | Traditional | PDF ↗ |
| K781498 | LIFELINE BIPOLAR PACING LEAD MOD. 466-01 | Intermedics, Inc. | 1979-02-01 | Traditional | PDF ↗ |
| K782087 | LEAD, SUTURELESS MYOCARDIAL | Daig Corp. | 1979-01-15 | Traditional | PDF ↗ |
| K781624 | PACING LEAD MODEL BUS 860, BUS 890 | R.E. Brown Co., Inc. | 1978-12-21 | Traditional | PDF ↗ |
| K782004 | LEAD, TIMED PACING, IMPLANTABLE | Daig Corp. | 1978-12-15 | Traditional | PDF ↗ |
| K781620 | PACING LEAD MODELS, MDM 1060, MDM 1090 | R.E. Brown Co., Inc. | 1978-12-08 | Traditional | PDF ↗ |
| K781623 | PACING MODELS MUM 860, MUM 890 | R.E. Brown Co., Inc. | 1978-12-08 | Traditional | PDF ↗ |
| K781619 | PACING LEAD MODELS SA, 350, SAM 500 | R.E. Brown Co., Inc. | 1978-12-08 | Traditional | PDF ↗ |
| K781625 | PACING LEAD MODEL MVM 860, MVM 890 | R.E. Brown Co., Inc. | 1978-12-08 | Traditional | PDF ↗ |
| K781621 | PACING LEAD MODELS, MAM 1260 MAM 1290 | R.E. Brown Co., Inc. | 1978-12-08 | Traditional | PDF ↗ |
| K781326 | UNIPOPLAR ENDOCARDIAL LEADS | American Technology, Inc. | 1978-12-04 | Traditional | PDF ↗ |
| K781456 | ENDOCARDIAL BIPOLAR LEAD | American Technology, Inc. | 1978-12-04 | Traditional | PDF ↗ |
| K781849 | ELECTRODES, IMPLANTABLE WITH ADAPTER | Telectronics, Inc. | 1978-12-04 | Traditional | PDF ↗ |
| K781776 | PACING LEADS MODEL UL-811 AND UL-813 | Pacesetter Systems | 1978-10-27 | Traditional | PDF ↗ |
| K780246 | PACEMAKER, ELECTRODE, PERMANENT & TEMP. | Daig Corp. | 1978-08-31 | Traditional | PDF ↗ |
| K780622 | BIPOLAR ENDOCARDIAL PACING LEAD, M. 6902 | Medtronic Vascular | 1978-07-28 | Traditional | PDF ↗ |
| K780623 | ENDOCARDIAL ATRIAL PACING LEAD, M. 6994 | Medtronic Vascular | 1978-07-28 | Traditional | PDF ↗ |
| K780621 | LEAD, PACING, ATRIAL, ENDOCARDIAL, TINED | Medtronic Vascular | 1978-07-26 | Traditional | PDF ↗ |
| K780569 | L-12, L-21, AND L-22 ELECTRODES | Coratomic, Inc. | 1978-06-14 | Traditional | PDF ↗ |
| K780446 | SUTURELESS MYOCARDIAL PACING LEAD | Medtronic Vascular | 1978-05-19 | Traditional | PDF ↗ |
| K772309 | ENDOCARDIAL PACING ELECTRODE | Coratomic, Inc. | 1978-02-06 | Traditional | PDF ↗ |
| K772197 | PACEMAKER, PERM. & TEMP., ELECTRODE | Daig Corp. | 1978-01-30 | Traditional | PDF ↗ |
| K772331 | RESTERIL. OF IMPLANT. ELECT. & ADAPTER | Telectronics, Inc. | 1978-01-11 | Traditional | PDF ↗ |
| K772203 | VENTRICULAR LEADS | Medtronic Vascular | 1978-01-11 | Traditional | PDF ↗ |
| K772104 | PACING LEAD MODEL 6991A | Medtronic Vascular | 1977-11-28 | Traditional | PDF ↗ |
| K772103 | BIPOLAR LEADS, DISP. | Medtronic Vascular | 1977-11-21 | Traditional | PDF ↗ |
| K771564 | ENDOCARD. PACIN/ LEAD-STD. LENGTH PL100 | Daig Corp. | 1977-09-14 | Traditional | PDF ↗ |
| K771566 | ENDOCAR. PACING LEAD-STD. LENGTH PL202 | Daig Corp. | 1977-09-14 | Traditional | PDF ↗ |
| K771567 | ENDOCARD. PACING LEAD-LONG LENGTH PL203 | Daig Corp. | 1977-09-14 | Traditional | PDF ↗ |
| K771565 | ENDOCARD. PACIN/ LEAD-LONG LENGTH PL200 | Daig Corp. | 1977-09-14 | Traditional | PDF ↗ |
| K771528 | CATHETER, CARDIAC PACING, ENDOCARDIAL | American Technology, Inc. | 1977-08-16 | Traditional | PDF ↗ |
| K770468 | UNIPOLAR LEAD CONFIGURATION CONDUCTOR | Daig Corp. | 1977-04-05 | Traditional | PDF ↗ |
| K770214 | TEMP. PERVENOUS LEAD W/REMOTE ANODE | Cordis Corp. | 1977-03-28 | Traditional | PDF ↗ |
| K770416 | LEAD, HEART, BUTTERFLY CLAMP | Arco Medical Products Co. | 1977-03-10 | Traditional | PDF ↗ |
| K770283 | WEDGE TIP, SMALL, MODEL #030-194 | Med Telectronics , Ltd. | 1977-02-24 | Traditional | PDF ↗ |
| K770284 | BALL TIP, MODEL #030-185 | Med Telectronics , Ltd. | 1977-02-24 | Traditional | PDF ↗ |
| K770282 | WEDGE TIP, SMALL, MODEL #030-191 | Med Telectronics , Ltd. | 1977-02-24 | Traditional | PDF ↗ |
| K770285 | BALL TIP, MODEL #030-188 | Med Telectronics , Ltd. | 1977-02-24 | Traditional | PDF ↗ |
| K770195 | PERM. IMPLANT. ENDOCARDIAL PAC. LEAD | Daig Corp. | 1977-02-07 | Traditional | PDF ↗ |
| K760714 | ENDO-LOK L-40 ENDOCARDIAL PACING ELECT. | Coratomic, Inc. | 1976-12-14 | Traditional | PDF ↗ |
| K760513 | ELECTRODE, TEMPORARY MYOCARDIAL | Winn Hirsch & Assoc. | 1976-10-15 | Traditional | PDF ↗ |
| K760443 | CARDIAC ELECTRODE | Meadox Medicals, Div. Boston Scientific Corp. | 1976-08-26 | Traditional | PDF ↗ |
Product code DTB · Class III · Cardiovascular. Data: openFDA.