510(k) K864618
- Device
- IMPLANTABLE ELECTRODE LEAD, MODEL 030-439
- Applicant
- TELECTRONICS, INC.
- 510(k) number
- K864618
- Product code
- DTB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-05-21
- Date received
- 1986-11-24
- Regulation
- 870.3680
- Classification name
- Permanent Pacemaker Electrode
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 3
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM C NEALON
- Address
- 40 Crane Hill Rd. Suffield CT US 06078 06078
FDA Registration Numbers#
- 1035166
- 1720929
- 3006705815
- 1028232
- 2648729
- 3005029049
- 2183787
- 3016678045
- 2183744
- 2649622
- 9616693
- 3013288201
- 3008494315
- 2017865
- 2124215
- 1061927
- 3008988055
- 3009380063
- 2032521
- 3018094310
- 9610139
- 3008973940
- 1928237
- 2182208
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DTB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K061212 | BIOTRONIK ENDOCARDIAL PACING LEADS | Biotronik, Inc. | 2006-07-10 |
| K041809 | PERMANENT PACING LEAD, MODEL PY2 | Oscor, Inc. | 2004-08-06 |
| K040569 | PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU | Oscor, Inc. | 2004-04-07 |
| K031274 | MODEL 5071 MYOCARDIAL PACING LEAD | Medtronic Vascular | 2003-05-22 |
| K031210 | MODEL 4951M MYOCARDIAL UNIPOLAR LEAD | Metronic, Inc. | 2003-05-16 |
| K023205 | ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP | Biotronik, Inc. | 2003-04-24 |
| K024053 | PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB | Oscor, Inc. | 2003-01-31 |
| K023803 | MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS | Biotronik, Inc. | 2002-12-11 |
| K023099 | AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP | Biotronik, Inc. | 2002-10-18 |
| K021217 | AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP | Biotronik, Inc. | 2002-05-01 |
| K010281 | MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP | Biotronik, Inc. | 2002-04-09 |
| K020669 | PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB | Oscor, Inc. | 2002-03-28 |
| K013339 | PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS | Oscor, Inc. | 2001-11-08 |
| K003918 | OSCOR PERMANENT PACING LEAD RZ MODEL SERIES | Oscor, Inc. | 2001-05-22 |
| K003072 | PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES | Biotronik, Inc. | 2001-01-09 |
Legacy Summary#
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FDA Review#
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