K852236 is an FDA 510(k) clearance for the MEDTRONIC MODEL 5867-1A. This device is classified as a Materials, Repair Or Replacement, Pacemaker (Class III - Premarket Approval, product code KFJ).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on July 11, 1985, 50 days after receiving the submission on May 22, 1985.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3710.
| 510(k) Number | K852236 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 1985 |
| Decision Date | July 11, 1985 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | KFJ — Materials, Repair Or Replacement, Pacemaker |
| Device Class | Class III - Premarket Approval |
| CFR Regulation | 21 CFR 870.3710 |