K202543 is an FDA 510(k) clearance for the OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by Volcano Corporation (San Diego, US). The FDA issued a Cleared decision on September 28, 2020, 26 days after receiving the submission on September 2, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K202543 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 2020 |
| Decision Date | September 28, 2020 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQX — Wire, Guide, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1330 |