The following data is part of a premarket notification filed by Cayenne Medical, Inc. with the FDA for Crossfix Ii Memiscal Repair Device.
| Device ID | K121413 |
| 510k Number | K121413 |
| Device Name: | CROSSFIX II MEMISCAL REPAIR DEVICE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | CAYENNE MEDICAL, INC. 16597 N. 92ND STREET SUITE 101 Scottsdale, AZ 85260 |
| Contact | Kereshmeh Shahriari |
| Correspondent | Kereshmeh Shahriari CAYENNE MEDICAL, INC. 16597 N. 92ND STREET SUITE 101 Scottsdale, AZ 85260 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-11 |
| Decision Date | 2012-06-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868270055 | K121413 | 000 |
| 00887868270048 | K121413 | 000 |