TEMPORARY PACEMAKER ELECTRODE
FDA 510(k) clearance K872972 · decided 1987-12-03
Clearance details
- K-number
- K872972
- Device name
- TEMPORARY PACEMAKER ELECTRODE
- Applicant
- Oscor Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1987-07-29
- Decision date
- 1987-12-03
- Days to decision
- 127 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
No recalls on record reference this clearance.