K001198 is an FDA 510(k) clearance for the DATASCOPE NITINOL CATHETER GUIDE WIRE (145 CM), DATASCOPE NITINOL CATHETER GUIDE WIRE (175 CM), DATASCOPE NITINOL CATHET. 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 May 12, 2000, 29 days after receiving the submission on April 13, 2000.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K001198 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 2000 |
| Decision Date | May 12, 2000 |
| Days to Decision | 29 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 |