TEMP. CARDIAC PACING WIRE TME 60/61/65
FDA 510(k) clearance K831695 · decided 1983-10-20
Clearance details
- K-number
- K831695
- Device name
- TEMP. CARDIAC PACING WIRE TME 60/61/65
- Applicant
- Oscor, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-05-25
- Decision date
- 1983-10-20
- Days to decision
- 148 days
- Clearance type
- Traditional
- Product code
- LDF
- Device class
- 2
- Regulation number
- 870.3680
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Palm Harbor, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing du recall (Z-0165-2013) | Oscor, Inc. | 2012-10-29 |