K011395 is an FDA 510(k) clearance for the MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B. This device is classified as a Ring, Annuloplasty (Class II - Special Controls, product code KRH).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on July 12, 2001, 66 days after receiving the submission on May 7, 2001.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3800.
| 510(k) Number | K011395 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 2001 |
| Decision Date | July 12, 2001 |
| Days to Decision | 66 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | KRH — Ring, Annuloplasty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3800 |