The following data is part of a premarket notification filed by Medtronic Blood Systems, Inc. with the FDA for Duran Flexible Annuloplasty Ring & Obturator H601h.
| Device ID | K893678 |
| 510k Number | K893678 |
| Device Name: | DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H |
| Classification | Ring, Annuloplasty |
| Applicant | MEDTRONIC BLOOD SYSTEMS, INC. 7000 CENTRAL AVENUE NE P.O. BOX 1350 Minneapolis, MN 55440 |
| Contact | Amy Peterson |
| Correspondent | Amy Peterson MEDTRONIC BLOOD SYSTEMS, INC. 7000 CENTRAL AVENUE NE P.O. BOX 1350 Minneapolis, MN 55440 |
| Product Code | KRH |
| CFR Regulation Number | 870.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-16 |
| Decision Date | 1989-11-27 |