The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Medtronic Colvin-galloway Future Annuloplasty Band, Model 638b.
| Device ID | K011395 |
| 510k Number | K011395 |
| Device Name: | MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B |
| Classification | Ring, Annuloplasty |
| Applicant | MEDTRONIC VASCULAR 8299 CENTRAL AVE., N.E. MAIL STOP: P108 Minneapolis, MN 55432 |
| Contact | Charles Dowd |
| Correspondent | Charles Dowd MEDTRONIC VASCULAR 8299 CENTRAL AVE., N.E. MAIL STOP: P108 Minneapolis, MN 55432 |
| Product Code | KRH |
| CFR Regulation Number | 870.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-07 |
| Decision Date | 2001-07-12 |