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 1 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K061212 | BIOTRONIK ENDOCARDIAL PACING LEADS | Biotronik, Inc. | 2006-07-10 | Special | PDF ↗ |
| K041809 | PERMANENT PACING LEAD, MODEL PY2 | Oscor, Inc. | 2004-08-06 | Special | PDF ↗ |
| K040569 | PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU | Oscor, Inc. | 2004-04-07 | Special | PDF ↗ |
| K031274 | MODEL 5071 MYOCARDIAL PACING LEAD | Medtronic Vascular | 2003-05-22 | Special | PDF ↗ |
| K031210 | MODEL 4951M MYOCARDIAL UNIPOLAR LEAD | Metronic, Inc. | 2003-05-16 | Special | PDF ↗ |
| K023205 | ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP | Biotronik, Inc. | 2003-04-24 | Traditional | PDF ↗ |
| K024053 | PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB | Oscor, Inc. | 2003-01-31 | Special | PDF ↗ |
| K023803 | MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS | Biotronik, Inc. | 2002-12-11 | Special | PDF ↗ |
| K023099 | AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP | Biotronik, Inc. | 2002-10-18 | Special | PDF ↗ |
| K021217 | AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP | Biotronik, Inc. | 2002-05-01 | Special | PDF ↗ |
| K010281 | MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP | Biotronik, Inc. | 2002-04-09 | Traditional | PDF ↗ |
| K020669 | PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB | Oscor, Inc. | 2002-03-28 | Special | PDF ↗ |
| K013339 | PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS | Oscor, Inc. | 2001-11-08 | Special | PDF ↗ |
| K003918 | OSCOR PERMANENT PACING LEAD RZ MODEL SERIES | Oscor, Inc. | 2001-05-22 | Traditional | PDF ↗ |
| K003072 | PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES | Biotronik, Inc. | 2001-01-09 | Traditional | PDF ↗ |
| K001413 | ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668 | Biotronik, Inc. | 2000-06-02 | Special | PDF ↗ |
| K994240 | EX 45-BP, MODEL 330 132; EX 53-BP, MODEL 130 018; EX 60-BP, MODEL 330 133 | Biotronik, Inc. | 2000-04-13 | Traditional | PDF ↗ |
| K993448 | STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS | Ela Medical, Inc. | 2000-04-10 | Traditional | PDF ↗ |
| K000763 | PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051 | Biotronik, GmbH & Co. | 2000-04-06 | Special | PDF ↗ |
| K000029 | STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS | Ela Medical, Inc. | 2000-04-04 | Traditional | PDF ↗ |
| K993139 | YP 45/15-BP; YP 53/15-BP; YP 60/15-BP | Biotronik, Inc. | 1999-12-17 | Traditional | PDF ↗ |
| K990142 | HT, MODEL HT PB | Sulzer Oscor, Inc. | 1999-07-30 | Traditional | PDF ↗ |
| K991169 | SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854 | Biotronik, Inc. | 1999-07-01 | Traditional | PDF ↗ |
| K990483 | RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777 | Biotronik, Inc. | 1999-06-03 | Traditional | PDF ↗ |
| K980869 | SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120 438 AND 120 143 | Biotronik, Inc. | 1998-09-10 | Traditional | PDF ↗ |
| K981083 | RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL NUMBERS 124 396, 124 397, 124 395, 124 000 | Biotronik, Inc. | 1998-07-22 | Traditional | PDF ↗ |
| K972500 | TIR/TIJ AND POLYROX | Biotronik, Inc. | 1998-03-04 | Traditional | PDF ↗ |
| K972814 | LOCATOR MODEL 4036 | Pacesetter, Inc. | 1998-02-23 | Traditional | PDF ↗ |
| K965106 | ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606 | Biotronik, Inc. | 1998-01-27 | Traditional | PDF ↗ |
| K972574 | STELA MODEL UJ45 PACING LEADS | Ela Medical, Inc. | 1998-01-08 | Traditional | PDF ↗ |
| K963738 | STELA MODEL BJ44 AND BJ45 PACING LEADS | Ela Medical, Inc. | 1997-05-23 | Traditional | PDF ↗ |
| K964107 | OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR | Oscor Medical Corp. | 1997-04-01 | Traditional | PDF ↗ |
| K964604 | BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION | Biotronik, Inc. | 1997-03-10 | Traditional | PDF ↗ |
| K954610 | MODEL 430-07 ENDOCARDIAL PACING LEAD | Intermedics, Inc. | 1996-12-16 | Traditional | PDF ↗ |
| K955122 | INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD | Intermedics, Inc. | 1996-11-04 | Traditional | PDF ↗ |
| K953044 | UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION & PASSIVE FIXATION | Biotronik, Inc. | 1996-09-27 | Traditional | PDF ↗ |
| K962036 | MEDTRONIC MODEL 5058 BIPOLAR, IMPLANTABLE, SCREW-IN, VENTRICULAR/ATRIAL, TRANSVENOUS LEAD | Medtronic Vascular | 1996-08-22 | Traditional | PDF ↗ |
| K962174 | BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07) | Intermedics, Inc. | 1996-08-21 | Traditional | PDF ↗ |
| K961936 | MODEL 2188 CORONARY SINUS LEAD. | Medtronic Vascular | 1996-08-15 | Traditional | PDF ↗ |
| K961679 | TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS/TRANSVENOUS, PERMANENT SCREW-IN PACING LEADS | Medtronic Vascular | 1996-07-30 | Traditional | PDF ↗ |
| K961118 | MAXIM PF MODELS 033-581/033-590 | Telectronics Pacing Systems, Inc. | 1996-07-15 | Traditional | PDF ↗ |
| K943657 | STERILIZATION | Telectronics Pacing Systems, Inc. | 1996-06-24 | Traditional | PDF ↗ |
| K955550 | CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD | Intermedics, Inc. | 1996-06-19 | Traditional | PDF ↗ |
| K960281 | IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY | Intermedics, Inc. | 1996-06-18 | Traditional | PDF ↗ |
| K954719 | INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD | Intermedics, Inc. | 1996-02-27 | Traditional | PDF ↗ |
| K954714 | AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION) | Pacesetter, Inc. | 1996-02-01 | Traditional | PDF ↗ |
| K954551 | DF-1 TERMINAL CAP | Pacesetter, Inc. | 1995-12-26 | Traditional | PDF ↗ |
| K954085 | MODELS 5866-45 AND 5866-46 SIZING SLEEVE | Medtronic Vascular | 1995-11-07 | Traditional | PDF ↗ |
| K951858 | TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS | Medtronic Vascular | 1995-10-12 | Traditional | PDF ↗ |
| K951950 | PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING | Pacesetter, Inc. | 1995-08-31 | Traditional | PDF ↗ |
| K952206 | PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING | Pacesetter, Inc. | 1995-08-31 | Traditional | PDF ↗ |
| K951087 | TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD | Pacesetter, Inc. | 1995-06-29 | Traditional | PDF ↗ |
| K940703 | MEDTRONIC MODEL 4558M | Medtronic Vascular | 1994-11-04 | Traditional | PDF ↗ |
| K942440 | AFP CARDIAC PACING SYSTEM MODEL 283 | Siemens-Pacesetter, Inc. | 1994-08-08 | Traditional | PDF ↗ |
| K925038 | PACING LEAD MODEL 1188T | Siemens-Pacesetter, Inc. | 1994-07-15 | Traditional | PDF ↗ |
| K932892 | PASSIVE PLUS ENDOCARDIAL PACING LEADS VAR. MODELS | Siemens-Pacesetter, Inc. | 1994-07-06 | Traditional | PDF ↗ |
| K930876 | SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146T | Siemens-Pacesetter, Inc. | 1994-06-15 | Traditional | PDF ↗ |
| K933055 | MEDTRONIS(R) PACING LEADS AND LEAD ADAPTORS, MODIF | Medtronic Vascular | 1994-05-02 | Traditional | PDF ↗ |
| K933731 | MEDTRONIC MODEL 5028 TARGET TIP, BIPOLAR, IMPLANTABLE, TINED, VENTRICULAR, TRANSVENOUS LEAD | Medtronic Vascular | 1994-03-21 | Traditional | PDF ↗ |
| K932172 | MEDTRONIC MODELS 4057M,4058M,4557M, PACING LEADS | Medtronic Vascular | 1993-12-08 | Traditional | PDF ↗ |
| K920662 | VASCOTWIST 9/60 | Vascor Medical Corp. | 1993-11-24 | Traditional | PDF ↗ |
| K931411 | MEDTRONIC MODEL 4081,4581,4582 TARGET TIP PACING L | Medtronic Vascular | 1993-09-23 | Traditional | PDF ↗ |
| K913831 | VASCO TIP/VASCOFLANGE | Vascor Medical Corp. | 1993-08-25 | Traditional | PDF ↗ |
| K914121 | VASCOSCREW 6/60 AND VASCOSCREW 8/60 | Vascor Medical Corp. | 1993-08-24 | Traditional | PDF ↗ |
| K932254 | MAXIMA FILTERED HARDSHELL RESERVOIR | Medtronic Vascular | 1993-08-03 | Traditional | PDF ↗ |
| K925099 | POSSIS MEDICAL MYOPORE BIPOLAR SUTURELESS MYCARDIA | Possis Medical, Inc. | 1993-06-22 | Traditional | PDF ↗ |
| K925347 | MODEL 1148T TRANSVENOUS, SCREW-IN LEAD | Siemens-Pacesetter, Inc. | 1993-06-10 | Traditional | PDF ↗ |
| K922042 | CARDIFIX ENDOCARDIAL PACING LEAD | Intermedics, Inc. | 1993-04-29 | Traditional | PDF ↗ |
| K922972 | MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD | Intermedics, Inc. | 1993-01-22 | Traditional | PDF ↗ |
| K920822 | CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE | Siemens-Pacesetter, Inc. | 1993-01-22 | Traditional | PDF ↗ |
| K915736 | MEDTRONIC MODELS 5069 AND 5071 MYOCARDIAL PACING | Medtronic Vascular | 1992-12-03 | Traditional | PDF ↗ |
| K915188 | MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD | Cook Pacemaker Corp. | 1992-09-11 | Traditional | PDF ↗ |
| K914489 | NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING | Telectronics Pacing Systems, Inc. | 1992-08-17 | Traditional | PDF ↗ |
| K921124 | MODELS 6917T, 6917AT & 4951M EPICARDIAL PACE LEADS | Medtronic Vascular | 1992-05-22 | Traditional | PDF ↗ |
| K912464 | PERMANENT CARDIAC PACING LEADS AND ADAPTORS | Medtronic Vascular | 1992-02-11 | Traditional | PDF ↗ |
| K912867 | OSCOR MEDICAL CORP PERMANENT PACING LEAD | Oscor Medical Corp. | 1992-02-04 | Traditional | PDF ↗ |
| K915008 | PERMANENT PACING PAD, MODIFICATION | Oscor Medical Corp. | 1992-01-27 | Traditional | PDF ↗ |
| K915007 | PERMANENT PACING LEADS, MODIFICATION | Oscor Medical Corp. | 1992-01-27 | Traditional | PDF ↗ |
| K913288 | MEDTRONIC UNIPOLAR, POLY PAC LEAD-BARR COAT COILS | Medtronic Vascular | 1991-10-17 | Traditional | PDF ↗ |
| K913393 | IMPLANT PACING LEAD, RETRACTABLE, MODIFICATION | Oscor Medical Corp. | 1991-09-23 | Traditional | PDF ↗ |
| K913204 | MODEL KY PACEMAKER LEAD-VARIOUS, MODIFICATION | Oscor Medical Corp. | 1991-09-23 | Traditional | PDF ↗ |
| K913205 | OSCOR MEDICAL FIX SCREW PAC LEAD/PEEL CATH, MODIF | Oscor Medical Corp. | 1991-09-23 | Traditional | PDF ↗ |
| K913202 | IMPLANT PACING LEAD, TINED #3262, MODIFICATION | Oscor Medical Corp. | 1991-09-23 | Traditional | PDF ↗ |
| K913201 | PRODUCTS IMPLANT PACING LEAD, TINED, MODIFICATION | Oscor Medical Corp. | 1991-09-23 | Traditional | PDF ↗ |
| K913158 | MODIFIED OSCOR PY PACING LEADS/MODIFICATION | Oscor Medical Corp. | 1991-09-23 | Traditional | PDF ↗ |
| K913203 | IMPLANT PACING LEAD TINED #3390, MODIFICATION | Oscor Medical Corp. | 1991-09-23 | Traditional | PDF ↗ |
| K912235 | MODELS 432-03 & 433-03 IMPLANT ENDOCARD PAC LEAD | Intermedics, Inc. | 1991-09-18 | Traditional | PDF ↗ |
| K910924 | ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE | Pacesetter Systems | 1991-08-28 | Traditional | PDF ↗ |
| K910609 | PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIP | Biotronik, GmbH & Co. | 1991-08-28 | Traditional | PDF ↗ |
| K911273 | 100 CM PERMANENT PACING LEAD MODELS | Telectronics Pacing Systems, Inc. | 1991-08-28 | Traditional | PDF ↗ |
| K910528 | BIPOLAR SUTURELESS MYOCARDIAL PACING LEADS | Possis Medical, Inc. | 1991-08-09 | Traditional | PDF ↗ |
| K910608 | PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIP | Biotronik, GmbH & Co. | 1991-07-30 | Traditional | PDF ↗ |
| K905300 | PERMANENT PACING LEAD | Oscor Medical Corp. | 1991-05-07 | Traditional | PDF ↗ |
| K905182 | OSCOR MEDICAL CORP. PERMANENT PACING PAD | Oscor Medical Corp. | 1991-05-07 | Traditional | PDF ↗ |
| K903948 | INTERMEDICS MODEL 431-11 IMPLANT ENDOCARD PAC LEAD | Intermedics, Inc. | 1991-04-22 | Traditional | PDF ↗ |
| K902672 | INTERMEDICS 430-07 BIPOL IMPLANT ENDOCARD PAC LEAD | Intermedics, Inc. | 1991-03-01 | Traditional | PDF ↗ |
| K904255 | FOCUS T41,T41F,T43, T43F,T44F | Elamedical | 1991-01-18 | Traditional | PDF ↗ |
| K904741 | LASERDISH POLY UNIPOLAR VENTRI LEAD W/TRAIL TINES | Telectronics Pacing Systems, Inc. | 1991-01-08 | Traditional | PDF ↗ |
| K903221 | LASERDISH SILICONE VENTRICULAR LEAD W/TRAILING TIN | Telectronics Pacing Systems, Inc. | 1990-11-08 | Traditional | PDF ↗ |
| K903929 | LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 60-UP | Biotronik, GmbH & Co. | 1990-10-16 | Traditional | PDF ↗ |
Product code DTB · Class III · Cardiovascular. Data: openFDA.