The following data is part of a premarket notification filed by Medtronic with the FDA for Tri-ad 2.0 Adams Tricuspid Band.
| Device ID | K181132 |
| 510k Number | K181132 |
| Device Name: | Tri-Ad 2.0 Adams Tricuspid Band |
| Classification | Ring, Annuloplasty |
| Applicant | Medtronic 1851 East Deere Ave Santa Ana, CA 92705 |
| Contact | Tracy Gray |
| Correspondent | Tracy Gray Medtronic 1851 East 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 | 2018-04-30 |
| Decision Date | 2018-05-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000102357 | K181132 | 000 |
| 00763000102340 | K181132 | 000 |
| 00763000102333 | K181132 | 000 |
| 00763000102326 | K181132 | 000 |
| 00763000102319 | K181132 | 000 |
| 00763000102302 | K181132 | 000 |