K925074 is an FDA 510(k) clearance for the USCI LUMISILK GUIDE WIRE WITH PRO/PEL COATING. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on March 1, 1993, 145 days after receiving the submission on October 7, 1992.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K925074 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 1992 |
| Decision Date | March 01, 1993 |
| Days to Decision | 145 days |
| Submission Type | Traditional |
| 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 |