The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Verrata Pressure Guide Wire.
| Device ID | K131288 |
| 510k Number | K131288 |
| Device Name: | VERRATA PRESSURE GUIDE WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | VOLCANO CORPORATION 2870 KILGORE RD. Rancho Cordova, CA 95670 |
| Contact | Jwala Jawharkar |
| Correspondent | Jwala Jawharkar VOLCANO CORPORATION 2870 KILGORE RD. Rancho Cordova, CA 95670 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-06 |
| Decision Date | 2013-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845225002466 | K131288 | 000 |
| 00845225002459 | K131288 | 000 |
| 00845225002442 | K131288 | 000 |
| 00845225002435 | K131288 | 000 |