The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Verrata Plus Pressure Guide Wire.
| Device ID | K210235 |
| 510k Number | K210235 |
| Device Name: | Verrata PLUS Pressure Guide Wire |
| Classification | Wire, Guide, Catheter |
| Applicant | Volcano Corporation 3721 Valley Centre Drive, Ste 500 San Diego, CA 92130 |
| Contact | Leilani Taylor |
| Correspondent | Leilani Taylor Volcano Corporation 3721 Valley Centre Drive, Ste 500 San Diego, CA 92130 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-28 |
| Decision Date | 2021-04-15 |