K070487 is an FDA 510(k) clearance for the SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX. This device is classified as a Transducer, Pressure, Catheter Tip (Class II - Special Controls, product code DXO).
Submitted by Volcano Corporation (Rancho Cordova,, US). The FDA issued a Cleared decision on March 16, 2007, 24 days after receiving the submission on February 20, 2007.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2870.
| 510(k) Number | K070487 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 20, 2007 |
| Decision Date | March 16, 2007 |
| Days to Decision | 24 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXO — Transducer, Pressure, Catheter Tip |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2870 |