The following data is part of a premarket notification filed by Traverse Vascular, Inc. with the FDA for Quikpass Catheter.
| Device ID | K214106 |
| 510k Number | K214106 |
| Device Name: | QuikPass Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | Traverse Vascular, Inc. 535 Stevens Ave. West Solana Beach, CA 92075 |
| Contact | Greg Geissinger |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-12-29 |
| Decision Date | 2022-01-28 |