TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1
FDA 510(k) clearance K884866 · decided 1989-03-22
Clearance details
- K-number
- K884866
- Device name
- TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1
- Applicant
- Oscor Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1988-11-21
- Decision date
- 1989-03-22
- Days to decision
- 121 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 |
|---|---|---|
| TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, recall (Z-0391-2019) | Oscor, Inc. | 2018-11-08 |