TORQUE HEX WRENCH
FDA 510(k) clearance K875147 · decided 1988-01-27
Clearance details
- K-number
- K875147
- Device name
- TORQUE HEX WRENCH
- Applicant
- Cardiac Pacemakers, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-12-15
- Decision date
- 1988-01-27
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- DTF
- Device class
- 1
- Regulation number
- 870.3730
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- St. Paul, MN, 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 |
|---|---|---|
| WRENCH, GEXAGON, DRIVER (K781179) | Telectronics, Inc. | 1978-07-27 |
Recalls involving this device
No recalls on record reference this clearance.