K922105 is an FDA 510(k) clearance for the USCI LINX EZ GUIDE WIRE EXTEN. W/ PRO/PEL COATING. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on November 17, 1992, 195 days after receiving the submission on May 6, 1992.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K922105 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 1992 |
| Decision Date | November 17, 1992 |
| Days to Decision | 195 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQO — Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |