The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Smartwire Pressure Guide Wire, Model 66xx.
| Device ID | K070487 |
| 510k Number | K070487 |
| Device Name: | SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX |
| Classification | Transducer, Pressure, Catheter Tip |
| Applicant | VOLCANO CORPORATION 2870 KILGORE RD. Rancho Cordova, CA 95670 |
| Contact | Cynthia Van Duker |
| Correspondent | Cynthia Van Duker VOLCANO CORPORATION 2870 KILGORE RD. Rancho Cordova, CA 95670 |
| Product Code | DXO |
| CFR Regulation Number | 870.2870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-20 |
| Decision Date | 2007-03-16 |
| Summary: | summary |