K875147 is an FDA 510(k) clearance for the TORQUE HEX WRENCH. This device is classified as a Tools, Pacemaker Service (Class I - General Controls, product code DTF).
Submitted by Cardiac Pacemakers, Inc. (St. Paul, US). The FDA issued a Cleared decision on January 27, 1988, 43 days after receiving the submission on December 15, 1987.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3730.
| 510(k) Number | K875147 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 1987 |
| Decision Date | January 27, 1988 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DTF — Tools, Pacemaker Service |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 870.3730 |