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 3 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K862054 | MODEL 430-01 BIOPORE IMPLANTABLE PACING LEAD | Intermedics, Inc. | 1986-09-19 | Traditional | PDF ↗ |
| K862053 | MODEL 432-01 BIOPORE IMPLANTABLE PACING LEAD | Intermedics, Inc. | 1986-09-19 | Traditional | PDF ↗ |
| K861493 | OSCOR MEDICAL FIX SCREW PACING LEAD/PEELABLE CATH | Oscor Medical Corp. | 1986-08-28 | Traditional | PDF ↗ |
| K862330 | MODIFIED OSCOR PY PACING LEADS | Oscor Medical Corp. | 1986-08-08 | Traditional | PDF ↗ |
| K832422 | CORDIS ANCOR ACTIVE FIXATION LEAD | Cordis Corp. | 1986-08-05 | Traditional | PDF ↗ |
| K851064 | CORDIS HI-FLEX PERVENOUS ACTIVE FIXATION UNIPOLAR | Cordis Corp. | 1986-08-05 | Traditional | PDF ↗ |
| K861767 | IMPLANTABLE ELECTRODE LEAD, MODEL 030-436 | Telectronics, Inc. | 1986-07-18 | Traditional | PDF ↗ |
| K862259 | MODEL 433-01 BIOPORE IMPLANTABLE PACING LEAD | Intermedics, Inc. | 1986-07-10 | Traditional | PDF ↗ |
| K862443 | MEDTRONIC TEMPORARY AND IMPLANTABLE PACING LEADS | Medtronic Vascular | 1986-07-10 | Traditional | PDF ↗ |
| K862258 | MODEL 437-01 BIOPORE IMPLANTABLE PACING LEAD | Intermedics, Inc. | 1986-07-10 | Traditional | PDF ↗ |
| K862257 | MODEL 431-02 BIOPORE IMPLANTABLE PACING LEAD | Intermedics, Inc. | 1986-07-10 | Traditional | PDF ↗ |
| K862052 | MODEL 438-01 CARDIFIX IMPLANTABLE PACING LEAD | Intermedics, Inc. | 1986-07-03 | Traditional | PDF ↗ |
| K862276 | MODEL 435-02 CARDIFIX IMPLANTABLE PACING LEAD | Intermedics, Inc. | 1986-07-02 | Traditional | PDF ↗ |
| K860846 | CORDIS HI-FLEX PERVENOUS BIPOLAR LEAD | Cordis Corp. | 1986-06-26 | Traditional | PDF ↗ |
| K854963 | S80 IMPLANTABLE CARDIAC PACING LEAD | Sorin Biomedica, Fiat, USA, Inc. | 1986-06-24 | Traditional | PDF ↗ |
| K860548 | MODEL 492-02 ENDOCARDIAL PACING LEAD | Intermedics, Inc. | 1986-06-13 | Traditional | PDF ↗ |
| K860547 | MODEL 486-02 ENDOCARDIAL PACING LEAD | Intermedics, Inc. | 1986-06-13 | Traditional | PDF ↗ |
| K861481 | ENDOCARDIAL CARBON-TIP LEAD | Pacesetter Systems | 1986-06-06 | Traditional | PDF ↗ |
| K861464 | LEAD BODY CHANGES TO HI PERFORM & FAST-PASS LEADS | Pacesetter Systems | 1986-05-19 | Traditional | PDF ↗ |
| K861440 | LEADS UTILIZ VOLUN STAND #1 3.2 MM UNI/BIOPOLAR CO | Pacesetter Systems | 1986-05-13 | Traditional | PDF ↗ |
| K853566 | DJ UNIPOLAR | Biotronik Sales, Inc. | 1986-05-07 | Traditional | PDF ↗ |
| K853567 | DJP UNIPOLAR | Biotronik Sales, Inc. | 1986-05-07 | Traditional | PDF ↗ |
| K861176 | MODEL 366-20 ADAPTAID STEP-DOWN ADAPTER | Intermedics, Inc. | 1986-04-29 | Traditional | PDF ↗ |
| K861110 | MODEL 366-10 ADAPTAID STEP-DOWN ADAPTER | Intermedics, Inc. | 1986-04-23 | Traditional | PDF ↗ |
| K860986 | MODEL 366-09 ADAPTAID ADAPTER SLEEVE | Intermedics, Inc. | 1986-03-31 | Traditional | PDF ↗ |
| K860985 | MODEL 366-19 ADAPTAID ADAPTER SLEEVE | Intermedics, Inc. | 1986-03-31 | Traditional | PDF ↗ |
| K854918 | MODEL 431-01 BIOPORE IMPLANTABLE PACING LEAD | Intermedics, Inc. | 1986-03-11 | Traditional | PDF ↗ |
| K854917 | MODEL 435-01 CARDIFIX IMPLANTABLE PACING LEAD | Intermedics, Inc. | 1986-03-11 | Traditional | PDF ↗ |
| K854128 | OSCOR MEDICAL UNIPOLAR PERMANENT PACING LEAD-CONNE | Oscor Medical Corp. | 1986-02-26 | Traditional | PDF ↗ |
| K854142 | STYLET INTRODUCER FUNNEL | Telectronics, Inc. | 1986-01-15 | Traditional | PDF ↗ |
| K853568 | DNR UNIPOLAR | Biotronik Sales, Inc. | 1986-01-15 | Traditional | PDF ↗ |
| K853446 | POLYSAFE CCS TRIFIX ENDOCARDIAL PACING LEAD SV-107 | Cardiac Control Systems, Inc. | 1986-01-13 | Traditional | PDF ↗ |
| K854582 | MOD TARGET/TIPS # 4011,4012,4511,4512,6912,4016 | Medtronic Vascular | 1986-01-13 | Traditional | PDF ↗ |
| K853747 | NAVIGATOR | Mainsfield Scientific, Inc. | 1986-01-08 | Traditional | PDF ↗ |
| K854069 | POLYFLEX 483-09 ENDOCARDIAL IMPLANTABLE PACINGLEAD | Intermedics, Inc. | 1985-12-09 | Traditional | PDF ↗ |
| K853850 | EXPLORER | Mansfield Scientific, Inc. | 1985-12-04 | Traditional | PDF ↗ |
| K852710 | IMPLANT ELECT LEAD MOD 30-404 USING POLYU 90 A | Telectronics, Inc. | 1985-12-04 | Traditional | PDF ↗ |
| K853521 | POLYFLEX IMPLANTABLE PACING LEAD-476-07 | Intermedics, Inc. | 1985-12-04 | Traditional | PDF ↗ |
| K853294 | CCS MODEL BV-114 IMPLANTABLE ENDOCARDIAL BIPOLARPA | Cardiac Control Systems, Inc. | 1985-12-04 | Traditional | PDF ↗ |
| K853398 | MEDTRONIC MODEL 5062 | Medtronic Vascular | 1985-12-04 | Traditional | PDF ↗ |
| K854405 | PACESETTER SYSTEMS ENDOCARDIAL SMALL FIN LEAD | Pacesetter Systems | 1985-12-04 | Traditional | PDF ↗ |
| K854220 | PACESETTER SYSEMS ENDOCARDIAL TRI-FIX LEAD | Pacesetter Systems | 1985-12-04 | Traditional | PDF ↗ |
| K854071 | POLYFLEX 493-07 ENDOCARDIAL IMPLANTABLE PAC-LEAD | Intermedics, Inc. | 1985-12-04 | Traditional | PDF ↗ |
| K853517 | LIFELINE ENDOCARDIAL UNIPOLAR LEAD 483-08 | Intermedics, Inc. | 1985-12-04 | Traditional | PDF ↗ |
| K853914 | PACESETTER SYS FAST PASS ENDOCARDIAL LEAD 856 INLI | Pacesetter Systems | 1985-12-03 | Traditional | PDF ↗ |
| K853518 | LIFELINE ENDOCARDIAL BIPOLAR LEAD 476-06 | Intermedics, Inc. | 1985-11-05 | Traditional | PDF ↗ |
| K853519 | LIFELINE ENDOCARDIAL BIPOLAR LEAD 484-03 | Intermedics, Inc. | 1985-10-24 | Traditional | PDF ↗ |
| K853520 | LIFELINE ENDOCARDIAL UNIPOLAR 487-06 TLE LEAD | Intermedics, Inc. | 1985-10-08 | Traditional | PDF ↗ |
| K852708 | IMPLANT ELECT LEAD, MOD 030-405 USING POLYU 90 A | Telectronics, Inc. | 1985-10-01 | Traditional | PDF ↗ |
| K853411 | MODEL 486-03 POLY FLEX IMPLANTABLE PACING LEAD | Intermedics, Inc. | 1985-10-01 | Traditional | PDF ↗ |
| K853221 | SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD,#30-401 | Telectronics, Inc. | 1985-09-17 | Traditional | PDF ↗ |
| K852446 | ENDOCARDIAL SCREW-IN LEAD WITH PLATINUM POROUS TIP | Diag Corp. | 1985-09-17 | Traditional | PDF ↗ |
| K853223 | SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, #30-407 | Telectronics, Inc. | 1985-09-17 | Traditional | PDF ↗ |
| K852709 | IMPLANT ELECT LEAD, MOD 30-403 USING POLYU 90 A | Telectronics, Inc. | 1985-09-17 | Traditional | PDF ↗ |
| K853222 | SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, #30-402 | Telectronics, Inc. | 1985-09-17 | Traditional | PDF ↗ |
| K852972 | IMPLANTABLE ELECTRODE LEAD, MODEL 030-400 | Telectronics, Inc. | 1985-09-16 | Traditional | PDF ↗ |
| K852119 | TEMPORARY PACEMAKER GROUND WIRE | Scholten Surgical Instruments, Inc. | 1985-09-15 | Traditional | PDF ↗ |
| K851731 | ELA MEDICAL PACING LEADS PMC 860 PMCF 860 PBCF860 | Ela Medical, Inc. | 1985-08-29 | Traditional | PDF ↗ |
| K852915 | SLIM VENT UNIPO PACING LEAD USING POLYU 90A,30-281 | Telectronics, Inc. | 1985-07-29 | Traditional | PDF ↗ |
| K851461 | IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLE | Telectronics, Inc. | 1985-07-11 | Traditional | PDF ↗ |
| K850623 | OSCOR MEDICAL IMPLANTABLE PACING LEAD, RETRACTABLE | Oscor Medical Corp. | 1985-04-19 | Traditional | PDF ↗ |
| K851296 | IMPLANTABLE ELECTRODE LEAD 030-269 USING POLYURETH | Telectronics, Inc. | 1985-04-11 | Traditional | PDF ↗ |
| K851294 | IMPLANTABLE ELECTRODE LEAD 030-272 USING POLYURETH | Telectronics, Inc. | 1985-04-10 | Traditional | PDF ↗ |
| K850065 | ELECATH TORKFLOAT PACING PROBE | Electro-Catheter Corp. | 1985-04-10 | Traditional | PDF ↗ |
| K851297 | IMPLANTABLE ELECTRODE LEAD, 030-270 USING POLYURET | Telectronics, Inc. | 1985-04-10 | Traditional | PDF ↗ |
| K851295 | IMPLANTABLE ELECTRODE LEAD 030-271 USING POLYURETH | Telectronics, Inc. | 1985-04-10 | Traditional | PDF ↗ |
| K820267 | INTERMEDICS POLYFLEX PACING LEAD #480-01 | Intermedics, Inc. | 1985-04-03 | Traditional | PDF ↗ |
| K813135 | MODEL 486-01 PACEMAKER LEAD | Intermedics, Inc. | 1985-04-03 | Traditional | PDF ↗ |
| K802294 | POLY FLEX IMPLANTABLE PACING LEAD | Intermedics, Inc. | 1985-04-03 | Traditional | PDF ↗ |
| K813136 | MODEL 492-01 PACEMAKER LEAD | Intermedics, Inc. | 1985-04-03 | Traditional | PDF ↗ |
| K844271 | MODEL 479-01 PACING LEAD | Intermedics, Inc. | 1985-03-28 | Traditional | PDF ↗ |
| K844266 | MODEL 492-01 PACING LEAD | Intermedics, Inc. | 1985-03-28 | Traditional | PDF ↗ |
| K844262 | MODEL 483-01 PACING LEAD | Intermedics, Inc. | 1985-03-28 | Traditional | PDF ↗ |
| K844260 | MODEL 476-03 PACING LEAD | Intermedics, Inc. | 1985-03-28 | Traditional | PDF ↗ |
| K844265 | MODEL 495-01 PACING LEAD | Intermedics, Inc. | 1985-03-28 | Traditional | PDF ↗ |
| K844268 | MODEL 483-03 PACING LEAD | Intermedics, Inc. | 1985-03-28 | Traditional | PDF ↗ |
| K844272 | MODEL 473-03 PACING LEAD | Intermedics, Inc. | 1985-03-28 | Traditional | PDF ↗ |
| K844261 | MODEL 490-01 PACING LEAD | Intermedics, Inc. | 1985-03-28 | Traditional | PDF ↗ |
| K844264 | MODEL 493-03 PACING LEAD | Intermedics, Inc. | 1985-03-28 | Traditional | PDF ↗ |
| K844269 | MODEL 483-02 PACING LEAD | Intermedics, Inc. | 1985-03-28 | Traditional | PDF ↗ |
| K844259 | MODEL 486-01 PACING LEAD | Intermedics, Inc. | 1985-03-28 | Traditional | PDF ↗ |
| K844263 | MODEL 493-01 PACING LEAD | Intermedics, Inc. | 1985-03-28 | Traditional | PDF ↗ |
| K844270 | MODEL 480-01 PACING LEAD | Intermedics, Inc. | 1985-03-28 | Traditional | PDF ↗ |
| K844267 | MODEL 483-01 PACING LEAD | Intermedics, Inc. | 1985-03-28 | Traditional | PDF ↗ |
| K844970 | CORDIS ENCOR PERVENOUS ATRIAL & VENTRICULAR LEADS | Cordis Corp. | 1985-03-27 | Traditional | PDF ↗ |
| K842031 | TRANSVENOUS TINED VENTRICULAR/ATRIAL | Medtronic Vascular | 1985-01-18 | Traditional | PDF ↗ |
| K842032 | MODELS 4012/4512 TRANSVENOUS TINED- | Medtronic Vascular | 1985-01-18 | Traditional | PDF ↗ |
| K844959 | MEDTRONIC 6304, 6305,6306,6506 & 6506W. TEMP.PACIN | Medtronic Vascular | 1985-01-10 | Traditional | PDF ↗ |
| K843707 | MEDTRONIC 6957J | Medtronic Vascular | 1985-01-08 | Traditional | PDF ↗ |
| K844752 | TRANSVENOUS BALLOON TIPPED(FLOW DIRECTED) TEMP. PA | Mansfield Scientific, Inc. | 1985-01-02 | Traditional | PDF ↗ |
| K811259 | CORDIS ENCOR ATRIAL LEAD | Cordis Corp. | 1984-12-27 | Traditional | PDF ↗ |
| K843706 | MEDTRONIC 6957 | Medtronic Vascular | 1984-12-27 | Traditional | PDF ↗ |
| K843393 | LIFELINE TLE 476-04 | Intermedics, Inc. | 1984-09-24 | Traditional | PDF ↗ |
| K843394 | LIFELINE TLE 484-02 | Intermedics, Inc. | 1984-09-24 | Traditional | PDF ↗ |
| K840668 | ELECTRODE PACEMAKER, PERM & TEMP | Vitatron Medical BV | 1984-09-24 | Traditional | PDF ↗ |
| K834431 | PACING ELECTRODE | Pacesetter Systems | 1984-03-12 | Traditional | PDF ↗ |
| K834342 | CCS MODEL AV-102 IMPLANTABLE A-V DATA | Cardiac Control Systems, Inc. | 1984-02-04 | Traditional | PDF ↗ |
| K834533 | ELECTRODE LEAD CONSTRUCTION | Telectronics, Inc. | 1984-01-30 | Traditional | PDF ↗ |
| K833824 | ENDOCARDIAL SCREW-IN LEAD 859 & 861 | Pacesetter Systems | 1983-12-01 | Traditional | PDF ↗ |
| K833106 | BIOTRONIK DFH UNIPOLAR PE-60/4-DFH | Biotronik Sales, Inc. | 1983-10-20 | Traditional | PDF ↗ |
Product code DTB · Class III · Cardiovascular. Data: openFDA.