K901347 is an FDA 510(k) clearance for the DATASCOPE SLIDEWIRE(TM). This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by Datascope Corp. (Oakland, US). The FDA issued a Cleared decision on June 21, 1990, 90 days after receiving the submission on March 23, 1990.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K901347 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 1990 |
| Decision Date | June 21, 1990 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | DQX - Wire, Guide, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1330 |