The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Verrata Plus Pressure Guide Wire, 185 Cm Straight Tip, Verrata Plus Pressure Guide Wire, 185 Cm J-tip, Verrata Plus Pressure Guide Wire, 300 Cm Straight Tip, Verrata Plus Pressure Guide Wire, 300 Cm J-tip.
| Device ID | K161887 |
| 510k Number | K161887 |
| Device Name: | Verrata PLUS Pressure Guide Wire, 185 Cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 Cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 Cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 Cm J-Tip |
| Classification | Wire, Guide, Catheter |
| Applicant | Volcano Corporation 3721 Valley Centre Drive Suite 500 San Diego, CA 92130 |
| Contact | Brian Park |
| Correspondent | Brian Park Volcano Corporation 3721 Valley Centre Drive Suite 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 | 2016-07-11 |
| Decision Date | 2016-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845225002909 | K161887 | 000 |
| 00845225002893 | K161887 | 000 |
| 00845225002886 | K161887 | 000 |
| 00845225002879 | K161887 | 000 |