K852612 is an FDA 510(k) clearance for the METRONIC MODEL F7700 HEART VALVE SIZERS. This device is classified as a Sizer, Heart-valve, Prosthesis (Class I - General Controls, product code DTI).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on September 23, 1985, 96 days after receiving the submission on June 19, 1985.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3945.
| 510(k) Number | K852612 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 1985 |
| Decision Date | September 23, 1985 |
| Days to Decision | 96 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DTI — Sizer, Heart-valve, Prosthesis |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 870.3945 |