K062769 is an FDA 510(k) clearance for the PRESSUREWIRE CERTUS, MODELS 12006 AND 12306. This device is classified as a Transducer, Pressure, Catheter Tip (Class II - Special Controls, product code DXO).
Submitted by Radi Medical Systems AB (Uppsala, SE). The FDA issued a Cleared decision on December 4, 2006, 80 days after receiving the submission on September 15, 2006.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2870.
| 510(k) Number | K062769 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 2006 |
| Decision Date | December 04, 2006 |
| Days to Decision | 80 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 |