The following data is part of a premarket notification filed by Tricol Biomedical Inc. with the FDA for Chitopulse 9in / 23 Cm, Chitopulse 12in / 30.5 Cm, Chitopulse 15in / 38 Cm.
| Device ID | K170958 |
| 510k Number | K170958 |
| Device Name: | ChitoPulse 9in / 23 Cm, ChitoPulse 12in / 30.5 Cm, ChitoPulse 15in / 38 Cm |
| Classification | Clamp, Vascular |
| Applicant | Tricol Biomedical Inc. 720 SW Washington Street, Suite 200 Portland, OR 97205 |
| Contact | Maire Ni Beilliu |
| Correspondent | Maire Ni Beilliu Tricol Biomedical Inc. 720 SW Washington Street, Suite 200 Portland, OR 97205 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-31 |
| Decision Date | 2017-08-29 |