K914986 is an FDA 510(k) clearance for the GUIDE WIRES, MODIFICATION. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by E-Z-Em, Inc. (Glens Falls, US). The FDA issued a Cleared decision on May 20, 1992, 209 days after receiving the submission on October 24, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K914986 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 24, 1991 |
| Decision Date | May 20, 1992 |
| Days to Decision | 209 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DQX — Wire, Guide, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1330 |