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 |
|---|---|---|---|
| Aug 31, 1995 | K951950 | PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING Pacesetter, Inc. | DTB |
| Jun 29, 1995 | K951087 | TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD Pacesetter, Inc. | DTB |
| Nov 4, 1994 | K940703 | MEDTRONIC MODEL 4558M Medtronic Vascular | DTB |
| Aug 8, 1994 | K942440 | AFP CARDIAC PACING SYSTEM MODEL 283 Siemens-Pacesetter, Inc. | DTB |
| Jul 15, 1994 | K925038 | PACING LEAD MODEL 1188T Siemens-Pacesetter, Inc. | DTB |
| Jul 6, 1994 | K932892 | PASSIVE PLUS ENDOCARDIAL PACING LEADS VAR. MODELS Siemens-Pacesetter, Inc. | DTB |
| Jun 15, 1994 | K930876 | SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146T Siemens-Pacesetter, Inc. | DTB |
| May 2, 1994 | K933055 | MEDTRONIS(R) PACING LEADS AND LEAD ADAPTORS, MODIF Medtronic Vascular | DTB |
| Mar 21, 1994 | K933731 | MEDTRONIC MODEL 5028 TARGET TIP, BIPOLAR, IMPLANTABLE, TINED, VENTRICULAR, TRANSVENOUS LEAD Medtronic Vascular | DTB |
| Dec 8, 1993 | K932172 | MEDTRONIC MODELS 4057M,4058M,4557M, PACING LEADS Medtronic Vascular | DTB |
| Nov 24, 1993 | K920662 | VASCOTWIST 9/60 Vascor Medical Corp. | DTB |
| Sep 23, 1993 | K931411 | MEDTRONIC MODEL 4081,4581,4582 TARGET TIP PACING L Medtronic Vascular | DTB |
| Aug 25, 1993 | K913831 | VASCO TIP/VASCOFLANGE Vascor Medical Corp. | DTB |
| Aug 24, 1993 | K914121 | VASCOSCREW 6/60 AND VASCOSCREW 8/60 Vascor Medical Corp. | DTB |
| Aug 3, 1993 | K932254 | MAXIMA FILTERED HARDSHELL RESERVOIR Medtronic Vascular | DTB |
| Jun 22, 1993 | K925099 | POSSIS MEDICAL MYOPORE BIPOLAR SUTURELESS MYCARDIA Possis Medical, Inc. | DTB |
| Jun 10, 1993 | K925347 | MODEL 1148T TRANSVENOUS, SCREW-IN LEAD Siemens-Pacesetter, Inc. | DTB |
| Apr 29, 1993 | K922042 | CARDIFIX ENDOCARDIAL PACING LEAD Intermedics, Inc. | DTB |
| Jan 22, 1993 | K922972 | MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD Intermedics, Inc. | DTB |
| Jan 22, 1993 | K920822 | CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE Siemens-Pacesetter, Inc. | DTB |
| Dec 3, 1992 | K915736 | MEDTRONIC MODELS 5069 AND 5071 MYOCARDIAL PACING Medtronic Vascular | DTB |
| Sep 11, 1992 | K915188 | MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD Cook Pacemaker Corp. | DTB |
| Aug 17, 1992 | K914489 | NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING Telectronics Pacing Systems, Inc. | DTB |
| May 22, 1992 | K921124 | MODELS 6917T, 6917AT & 4951M EPICARDIAL PACE LEADS Medtronic Vascular | DTB |
| Feb 11, 1992 | K912464 | PERMANENT CARDIAC PACING LEADS AND ADAPTORS Medtronic Vascular | DTB |
| Feb 4, 1992 | K912867 | OSCOR MEDICAL CORP PERMANENT PACING LEAD Oscor Medical Corp. | DTB |
| Jan 27, 1992 | K915008 | PERMANENT PACING PAD, MODIFICATION Oscor Medical Corp. | DTB |
| Jan 27, 1992 | K915007 | PERMANENT PACING LEADS, MODIFICATION Oscor Medical Corp. | DTB |
| Oct 17, 1991 | K913288 | MEDTRONIC UNIPOLAR, POLY PAC LEAD-BARR COAT COILS Medtronic Vascular | DTB |
| Sep 23, 1991 | K913393 | IMPLANT PACING LEAD, RETRACTABLE, MODIFICATION Oscor Medical Corp. | DTB |
| Sep 23, 1991 | K913205 | OSCOR MEDICAL FIX SCREW PAC LEAD/PEEL CATH, MODIF Oscor Medical Corp. | DTB |
| Sep 23, 1991 | K913204 | MODEL KY PACEMAKER LEAD-VARIOUS, MODIFICATION Oscor Medical Corp. | DTB |
| Sep 23, 1991 | K913203 | IMPLANT PACING LEAD TINED #3390, MODIFICATION Oscor Medical Corp. | DTB |
| Sep 23, 1991 | K913202 | IMPLANT PACING LEAD, TINED #3262, MODIFICATION Oscor Medical Corp. | DTB |
| Sep 23, 1991 | K913201 | PRODUCTS IMPLANT PACING LEAD, TINED, MODIFICATION Oscor Medical Corp. | DTB |
| Sep 23, 1991 | K913158 | MODIFIED OSCOR PY PACING LEADS/MODIFICATION Oscor Medical Corp. | DTB |
| Sep 18, 1991 | K912235 | MODELS 432-03 & 433-03 IMPLANT ENDOCARD PAC LEAD Intermedics, Inc. | DTB |
| Aug 28, 1991 | K911273 | 100 CM PERMANENT PACING LEAD MODELS Telectronics Pacing Systems, Inc. | DTB |
| Aug 28, 1991 | K910924 | ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE Pacesetter Systems | DTB |
| Aug 28, 1991 | K910609 | PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIP Biotronik, GmbH & Co. | DTB |
| Aug 9, 1991 | K910528 | BIPOLAR SUTURELESS MYOCARDIAL PACING LEADS Possis Medical, Inc. | DTB |
| Jul 30, 1991 | K910608 | PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIP Biotronik, GmbH & Co. | DTB |
| May 7, 1991 | K905300 | PERMANENT PACING LEAD Oscor Medical Corp. | DTB |
| May 7, 1991 | K905182 | OSCOR MEDICAL CORP. PERMANENT PACING PAD Oscor Medical Corp. | DTB |
| Apr 22, 1991 | K903948 | INTERMEDICS MODEL 431-11 IMPLANT ENDOCARD PAC LEAD Intermedics, Inc. | DTB |
| Mar 1, 1991 | K902672 | INTERMEDICS 430-07 BIPOL IMPLANT ENDOCARD PAC LEAD Intermedics, Inc. | DTB |
| Jan 18, 1991 | K904255 | FOCUS T41,T41F,T43, T43F,T44F Elamedical | DTB |
| Jan 8, 1991 | K904741 | LASERDISH POLY UNIPOLAR VENTRI LEAD W/TRAIL TINES Telectronics Pacing Systems, Inc. | DTB |
| Nov 8, 1990 | K903221 | LASERDISH SILICONE VENTRICULAR LEAD W/TRAILING TIN Telectronics Pacing Systems, Inc. | DTB |
| Oct 16, 1990 | K903929 | LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 60-UP Biotronik, GmbH & Co. | DTB |
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