Panels › Cardiovascular › Product code DTB · Class 3
Permanent Pacemaker Electrode
Regulation 870.3680
0510(k)s in 12 months (487 all time)
0recalls in 12 months (8 all time)
6recalls that name a 510(k)
Top companies in DTB
| Company | 510(k)s | Recalls |
|---|---|---|
| Intermedics, Inc. | 105 | 0 |
| Medtronic Vascular | 69 | 0 |
| Telectronics, Inc. | 35 | 0 |
| Pacesetter Systems | 33 | 0 |
| Daig Corp. | 28 | 0 |
| Biotronik, GmbH & Co. | 26 | 0 |
| Oscor Medical Corp. | 22 | 0 |
| Oscor, Inc. | 20 | 1 |
| Biotronik Sales, Inc. | 15 | 0 |
| Cordis Corp. | 13 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 19, 1986 | K862054 | MODEL 430-01 BIOPORE IMPLANTABLE PACING LEAD Intermedics, Inc. | DTB |
| Sep 19, 1986 | K862053 | MODEL 432-01 BIOPORE IMPLANTABLE PACING LEAD Intermedics, Inc. | DTB |
| Aug 28, 1986 | K861493 | OSCOR MEDICAL FIX SCREW PACING LEAD/PEELABLE CATH Oscor Medical Corp. | DTB |
| Aug 8, 1986 | K862330 | MODIFIED OSCOR PY PACING LEADS Oscor Medical Corp. | DTB |
| Aug 5, 1986 | K851064 | CORDIS HI-FLEX PERVENOUS ACTIVE FIXATION UNIPOLAR Cordis Corp. | DTB |
| Aug 5, 1986 | K832422 | CORDIS ANCOR ACTIVE FIXATION LEAD Cordis Corp. | DTB |
| Jul 18, 1986 | K861767 | IMPLANTABLE ELECTRODE LEAD, MODEL 030-436 Telectronics, Inc. | DTB |
| Jul 10, 1986 | K862443 | MEDTRONIC TEMPORARY AND IMPLANTABLE PACING LEADS Medtronic Vascular | DTB |
| Jul 10, 1986 | K862259 | MODEL 433-01 BIOPORE IMPLANTABLE PACING LEAD Intermedics, Inc. | DTB |
| Jul 10, 1986 | K862258 | MODEL 437-01 BIOPORE IMPLANTABLE PACING LEAD Intermedics, Inc. | DTB |
| Jul 10, 1986 | K862257 | MODEL 431-02 BIOPORE IMPLANTABLE PACING LEAD Intermedics, Inc. | DTB |
| Jul 3, 1986 | K862052 | MODEL 438-01 CARDIFIX IMPLANTABLE PACING LEAD Intermedics, Inc. | DTB |
| Jul 2, 1986 | K862276 | MODEL 435-02 CARDIFIX IMPLANTABLE PACING LEAD Intermedics, Inc. | DTB |
| Jun 26, 1986 | K860846 | CORDIS HI-FLEX PERVENOUS BIPOLAR LEAD Cordis Corp. | DTB |
| Jun 24, 1986 | K854963 | S80 IMPLANTABLE CARDIAC PACING LEAD Sorin Biomedica, Fiat, USA, Inc., IT | DTB |
| Jun 13, 1986 | K860548 | MODEL 492-02 ENDOCARDIAL PACING LEAD Intermedics, Inc. | DTB |
| Jun 13, 1986 | K860547 | MODEL 486-02 ENDOCARDIAL PACING LEAD Intermedics, Inc. | DTB |
| Jun 6, 1986 | K861481 | ENDOCARDIAL CARBON-TIP LEAD Pacesetter Systems | DTB |
| May 19, 1986 | K861464 | LEAD BODY CHANGES TO HI PERFORM & FAST-PASS LEADS Pacesetter Systems | DTB |
| May 13, 1986 | K861440 | LEADS UTILIZ VOLUN STAND #1 3.2 MM UNI/BIOPOLAR CO Pacesetter Systems | DTB |
| May 7, 1986 | K853567 | DJP UNIPOLAR Biotronik Sales, Inc. | DTB |
| May 7, 1986 | K853566 | DJ UNIPOLAR Biotronik Sales, Inc. | DTB |
| Apr 29, 1986 | K861176 | MODEL 366-20 ADAPTAID STEP-DOWN ADAPTER Intermedics, Inc. | DTB |
| Apr 23, 1986 | K861110 | MODEL 366-10 ADAPTAID STEP-DOWN ADAPTER Intermedics, Inc. | DTB |
| Mar 31, 1986 | K860986 | MODEL 366-09 ADAPTAID ADAPTER SLEEVE Intermedics, Inc. | DTB |
| Mar 31, 1986 | K860985 | MODEL 366-19 ADAPTAID ADAPTER SLEEVE Intermedics, Inc. | DTB |
| Mar 11, 1986 | K854918 | MODEL 431-01 BIOPORE IMPLANTABLE PACING LEAD Intermedics, Inc. | DTB |
| Mar 11, 1986 | K854917 | MODEL 435-01 CARDIFIX IMPLANTABLE PACING LEAD Intermedics, Inc. | DTB |
| Feb 26, 1986 | K854128 | OSCOR MEDICAL UNIPOLAR PERMANENT PACING LEAD-CONNE Oscor Medical Corp. | DTB |
| Jan 15, 1986 | K854142 | STYLET INTRODUCER FUNNEL Telectronics, Inc. | DTB |
| Jan 15, 1986 | K853568 | DNR UNIPOLAR Biotronik Sales, Inc. | DTB |
| Jan 13, 1986 | K854582 | MOD TARGET/TIPS # 4011,4012,4511,4512,6912,4016 Medtronic Vascular | DTB |
| Jan 13, 1986 | K853446 | POLYSAFE CCS TRIFIX ENDOCARDIAL PACING LEAD SV-107 Cardiac Control Systems, Inc. | DTB |
| Jan 8, 1986 | K853747 | NAVIGATOR Mainsfield Scientific, Inc. | DTB |
| Dec 9, 1985 | K854069 | POLYFLEX 483-09 ENDOCARDIAL IMPLANTABLE PACINGLEAD Intermedics, Inc. | DTB |
| Dec 4, 1985 | K854405 | PACESETTER SYSTEMS ENDOCARDIAL SMALL FIN LEAD Pacesetter Systems | DTB |
| Dec 4, 1985 | K854220 | PACESETTER SYSEMS ENDOCARDIAL TRI-FIX LEAD Pacesetter Systems | DTB |
| Dec 4, 1985 | K854071 | POLYFLEX 493-07 ENDOCARDIAL IMPLANTABLE PAC-LEAD Intermedics, Inc. | DTB |
| Dec 4, 1985 | K853850 | EXPLORER Mansfield Scientific, Inc. | DTB |
| Dec 4, 1985 | K853521 | POLYFLEX IMPLANTABLE PACING LEAD-476-07 Intermedics, Inc. | DTB |
| Dec 4, 1985 | K853517 | LIFELINE ENDOCARDIAL UNIPOLAR LEAD 483-08 Intermedics, Inc. | DTB |
| Dec 4, 1985 | K853398 | MEDTRONIC MODEL 5062 Medtronic Vascular | DTB |
| Dec 4, 1985 | K853294 | CCS MODEL BV-114 IMPLANTABLE ENDOCARDIAL BIPOLARPA Cardiac Control Systems, Inc. | DTB |
| Dec 4, 1985 | K852710 | IMPLANT ELECT LEAD MOD 30-404 USING POLYU 90 A Telectronics, Inc. | DTB |
| Dec 3, 1985 | K853914 | PACESETTER SYS FAST PASS ENDOCARDIAL LEAD 856 INLI Pacesetter Systems | DTB |
| Nov 5, 1985 | K853518 | LIFELINE ENDOCARDIAL BIPOLAR LEAD 476-06 Intermedics, Inc. | DTB |
| Oct 24, 1985 | K853519 | LIFELINE ENDOCARDIAL BIPOLAR LEAD 484-03 Intermedics, Inc. | DTB |
| Oct 8, 1985 | K853520 | LIFELINE ENDOCARDIAL UNIPOLAR 487-06 TLE LEAD Intermedics, Inc. | DTB |
| Oct 1, 1985 | K853411 | MODEL 486-03 POLY FLEX IMPLANTABLE PACING LEAD Intermedics, Inc. | DTB |
| Oct 1, 1985 | K852708 | IMPLANT ELECT LEAD, MOD 030-405 USING POLYU 90 A Telectronics, Inc. | DTB |
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