The following data is part of a premarket notification filed by Velano Vascular with the FDA for Velano Vascular Q2 Extension Set.
| Device ID | K182897 |
| 510k Number | K182897 |
| Device Name: | Velano Vascular Q2 Extension Set |
| Classification | Set, Administration, Intravascular |
| Applicant | Velano Vascular 221 Pine St. #200 San Francisco, CA 94104 |
| Contact | Tiffini Wittwer |
| Correspondent | Tiffini Wittwer Velano Vascular 221 Pine St. #200 San Francisco, CA 94104 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-16 |
| Decision Date | 2019-03-26 |