K943896 is an FDA 510(k) clearance for the GUIDE WIRE FOR THE USE WITH DATASCOPE PERCOR STAT-DL IABS. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by Datascope Corp. (Fairfield, US). The FDA issued a Cleared decision on December 22, 1995, 499 days after receiving the submission on August 10, 1994.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K943896 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 1994 |
| Decision Date | December 22, 1995 |
| Days to Decision | 499 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 |