DTB — Permanent Pacemaker Electrode Class III
FDA product code DTB covers "Permanent Pacemaker Electrode", a Class III medical device regulated under 21 CFR 870.3680. Submissions are reviewed by the Cardiovascular panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DTB
- Device Class
- Class III
- Regulation Number
- 870.3680
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K061212 | biotronik | BIOTRONIK ENDOCARDIAL PACING LEADS | July 10, 2006 |
| K041809 | oscor | PERMANENT PACING LEAD, MODEL PY2 | August 6, 2004 |
| K040569 | oscor | PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU | April 7, 2004 |
| K031274 | medtronic vascular | MODEL 5071 MYOCARDIAL PACING LEAD | May 22, 2003 |
| K031210 | metronic | MODEL 4951M MYOCARDIAL UNIPOLAR LEAD | May 16, 2003 |
| K023205 | biotronik | ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP | April 24, 2003 |
| K024053 | oscor | PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB | January 31, 2003 |
| K023803 | biotronik | MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS | December 11, 2002 |
| K023099 | biotronik | AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP | October 18, 2002 |
| K021217 | biotronik | AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP | May 1, 2002 |
| K010281 | biotronik | MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP | April 9, 2002 |
| K020669 | oscor | PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB | March 28, 2002 |
| K013339 | oscor | PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS | November 8, 2001 |
| K003918 | oscor | OSCOR PERMANENT PACING LEAD RZ MODEL SERIES | May 22, 2001 |
| K003072 | biotronik | PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES | January 9, 2001 |
| K001413 | biotronik | ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668 | June 2, 2000 |
| K994240 | biotronik | EX 45-BP, MODEL 330 132; EX 53-BP, MODEL 130 018; EX 60-BP, MODEL 330 133 | April 13, 2000 |
| K993448 | ela medical | STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHA | April 10, 2000 |
| K000763 | biotronik, gmbh and | PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051 | April 6, 2000 |
| K000029 | ela medical | STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHA | April 4, 2000 |