MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP
FDA 510(k) clearance K010281 · decided 2002-04-09
Clearance details
- K-number
- K010281
- Device name
- MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP
- Applicant
- Biotronik, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-01-30
- Decision date
- 2002-04-09
- Days to decision
- 434 days
- Clearance type
- Traditional
- Product code
- DTB
- Device class
- 3
- Regulation number
- 870.3680
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Lake Oswego, OR, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BIOTRONIK ENDOCARDIAL PACING LEADS (K061212) | Biotronik, Inc. | 2006-07-10 |
| PERMANENT PACING LEAD, MODEL PY2 (K041809) | Oscor, Inc. | 2004-08-06 |
| PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU (K040569) | Oscor, Inc. | 2004-04-07 |
| MODEL 5071 MYOCARDIAL PACING LEAD (K031274) | Medtronic Vascular | 2003-05-22 |
| MODEL 4951M MYOCARDIAL UNIPOLAR LEAD (K031210) | Metronic, Inc. | 2003-05-16 |
| ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP (K023205) | Biotronik, Inc. | 2003-04-24 |
| PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB (K024053) | Oscor, Inc. | 2003-01-31 |
| MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS (K023803) | Biotronik, Inc. | 2002-12-11 |
| AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP (K023099) | Biotronik, Inc. | 2002-10-18 |
| AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP (K021217) | Biotronik, Inc. | 2002-05-01 |
| PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB (K020669) | Oscor, Inc. | 2002-03-28 |
| PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS (K013339) | Oscor, Inc. | 2001-11-08 |
Recalls involving this device
No recalls on record reference this clearance.