The following data is part of a premarket notification filed by Cayenne Medical, Inc. with the FDA for Cuffink.
| Device ID | K112814 |
| 510k Number | K112814 |
| Device Name: | CUFFINK |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | CAYENNE MEDICAL, INC. 16597 N.92ND ST. SUITE 101 Scottsdale, AZ 85260 |
| Contact | Kereshmeh Shahriari |
| Correspondent | Kereshmeh Shahriari CAYENNE MEDICAL, INC. 16597 N.92ND ST. SUITE 101 Scottsdale, AZ 85260 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-27 |
| Decision Date | 2012-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868270970 | K112814 | 000 |
| 00887868270963 | K112814 | 000 |
| 00887868270956 | K112814 | 000 |
| 00887868270949 | K112814 | 000 |
| 00887868270291 | K112814 | 000 |
| 00887868270284 | K112814 | 000 |
| 00887868270277 | K112814 | 000 |