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 |
|---|---|---|---|
| Oct 16, 1990 | K903928 | LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP Biotronik, GmbH & Co. | DTB |
| Oct 16, 1990 | K903927 | LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 45-UP Biotronik, GmbH & Co. | DTB |
| Sep 26, 1990 | K902002 | MODELS 5069/5071 MYOCARDIAL PACING LEADS Medtronic Vascular | DTB |
| Aug 8, 1990 | K900645 | LASERDISH POLYURETHANE VENTRICULAR LEAD W/TRAILING Telectronics Pacing Systems, Inc. | DTB |
| Aug 8, 1990 | K896824 | BIOTRONIK'S PS-ENDOCARDIAL LEADS Biotronik, GmbH & Co. | DTB |
| Jul 17, 1990 | K902147 | ENDOCARDIAL SCREW-IN LEAD MODEL 1028T Pacesetter Systems | DTB |
| Jul 17, 1990 | K896742 | FOCUS J81F, J83F, J41F, J43F PACING LEADS Ela Medical, Inc. | DTB |
| Jun 12, 1990 | K901402 | VS-1 LEAD EXT. 033-302, 4.75MM 033-260, 033-458 Telectronics Pacing Systems, Inc. | DTB |
| May 22, 1990 | K901709 | DNP 60-B UNIPOLAR ENDOCARDIAL LEAD Biotronik, GmbH & Co. | DTB |
| May 3, 1990 | K900984 | MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1 Medtronic Vascular | DTB |
| Apr 20, 1990 | K900550 | FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T Pacesetter Systems | DTB |
| Mar 6, 1990 | K896313 | MEDTRONIC IMPLANTABLE PACING LEADS W/IS-1 CONN. Medtronic Vascular | DTB |
| Feb 8, 1990 | K895136 | PERMANENT AND TEMP. PACEMAKER ELECTRODE & LEAD ADA Medtronic Vascular | DTB |
| Feb 5, 1990 | K897067 | MODIFIED J-STIFFENER WIRE MATERIAL IN LEAD LINES Telectronics Pacing Systems, Inc. | DTB |
| Jan 18, 1990 | K892528 | FIVE-YEAR STERILE PACKAGING SHELF LIFE Daig Corp. | DTB |
| Dec 20, 1989 | K896443 | MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS Possis Medical, Inc. | DTB |
| Dec 20, 1989 | K895447 | ENDOCARDIAL SCREW-IN LEAD MODEL 1020T Pacesetter Systems | DTB |
| Nov 14, 1989 | K893041 | NEW ADHESIVE, PELLETHAN ON POLYURETHANE LEADS-MODI Telectronics Pacing Systems, Inc. | DTB |
| Jul 14, 1989 | K894040 | IMPLANTABLE PACING LEADS W/IS-1 CONN., UNIPOLAR Medtronic Vascular | DTB |
| Jul 14, 1989 | K893763 | MODELS 1113 AND 1114 PACEMAKER LEADS Possis Medical, Inc. | DTB |
| Jul 14, 1989 | K885175 | MYOPORE(TM) UNIPOLAR SUTURELESS MYOCARDIAL LEADS Possis Medical, Inc. | DTB |
| Jun 20, 1989 | K890018 | PACEMAKER LEAD ADAPTER Ela Medical, Inc. | DTB |
| Jun 5, 1989 | K891905 | CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE Pacesetter Systems | DTB |
| May 31, 1989 | K890644 | MEDTRONIC MODEL 5866-45 SIZING SLEEVE Medtronic Vascular | DTB |
| Apr 21, 1989 | K890527 | ALTERNATE PACKAGING CONFIGURATION FOR PACING LEADS Medtronic Vascular | DTB |
| Apr 19, 1989 | K884697 | HEPARIN BONDING FOR CATHETERS Daig Corp. | DTB |
| Mar 28, 1989 | K890412 | MODELS 430-07 & 431-07 IMPLANTABLE PACING LEADS Intermedics, Inc. | DTB |
| Mar 28, 1989 | K890411 | MODELS 432-03 & 433-03 IMPLANTABLE PACING LEADS Intermedics, Inc. | DTB |
| Mar 22, 1989 | K890547 | SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS Pacesetter Systems | DTB |
| Feb 22, 1989 | K884811 | ACCUFIX AND LASERDISH BIPOLAR VS-1 LEADS Telectronics and Control Pacing Systems | DTB |
| Feb 10, 1989 | K885240 | MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEAD Tpl-Cordis, Inc. | DTB |
| Feb 2, 1989 | K890350 | VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE) Telectronics, Inc. | DTB |
| Jan 30, 1989 | K890045 | MODEL 6208,6209,6210,6211,6212,6214 (PLI'S) Medtronic Vascular | DTB |
| Jan 17, 1989 | K883743 | MEDTRONIC MODEL 4058 PACING LEAD Medtronic Vascular | DTB |
| Dec 15, 1988 | K884278 | IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436 Telectronics, Inc. | DTB |
| Dec 8, 1988 | K884394 | PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F Ela Medical, Inc. | DTB |
| Dec 5, 1988 | K884005 | ENDOCARDIAL PACING LEADS-ANCHORING SLEEVE MODIFIED Medtronic Vascular | DTB |
| Dec 5, 1988 | K883070 | ENCOR UNIPOLAR VS-1 LEADS Cordis Leads, Inc. | DTB |
| Oct 28, 1988 | K882462 | PERMANENT PACING LEAD MODEL RXBJ SERIES Oscor Medical Corp. | DTB |
| Oct 28, 1988 | K882345 | PERMANENT PACING LEADS PYBJ SERIES Oscor Medical Corp. | DTB |
| Oct 19, 1988 | K873772 | CHANGES TO ENCOR PERVENOUS J-ATRIAL LEADS Cordis Leads, Inc. | DTB |
| Oct 14, 1988 | K884024 | POLYSAFE(TM) IMPLANTABLE PACING LEAD Cardiac Control Systems, Inc. | DTB |
| Oct 14, 1988 | K883265 | MODEL 329-701 BIPOLAR ACTIVE-FIXATION LEAD Telectronics and Cordis Pacing Systems | DTB |
| Oct 13, 1988 | K881810 | MEDTRONIC MODEL 4951P Medtronic Vascular | DTB |
| Oct 6, 1988 | K883015 | POLYSAFE IMPLANT. PACING LEADS W/TRABECULOK TIP Cardiac Control Systems, Inc. | DTB |
| Sep 16, 1988 | K883016 | POLYSAFE IMPLANT. PACING LEADS W/TINED FIXA. TIP Cardiac Control Systems, Inc. | DTB |
| Sep 6, 1988 | K883602 | BIOPORE VS.1 ENDOCARDIAL INTER IMPLANT PACING LEAD Intermedics, Inc. | DTB |
| Sep 6, 1988 | K883203 | MODEL 5866-34A PACEMAKER LEAD ADAPTOR Medtronic Vascular | DTB |
| Aug 25, 1988 | K882452 | MEDTRONIC MODELS 4057/4557 ENDOCARDIAL PACING LEAD Medtronic Vascular | DTB |
| Jun 16, 1988 | K874366 | ENCOR BIPOLAR ACT/FIXA LEAD W/POR SUR ELE #329-201 Cordis Leads, Inc. | DTB |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.