The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Simuplus Flexible Annuloplasty Ring, Simuplus Flexible Annuloplasty Band, Simuform Semi-rigid Annuloplasty Ring.
| Device ID | K201449 |
| 510k Number | K201449 |
| Device Name: | SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring |
| Classification | Ring, Annuloplasty |
| Applicant | Medtronic, Inc. 1851 E. Deere Ave. Santa Ana, CA 92705 |
| Contact | Lisa Corbin |
| Correspondent | Lisa Corbin Medtronic, Inc. 1851 E. Deere Ave. Santa Ana, CA 92705 |
| Product Code | KRH |
| CFR Regulation Number | 870.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-01 |
| Decision Date | 2020-07-01 |