K901391 is an FDA 510(k) clearance for the DATASCOPE PTCA PERCUTANEOUS CATHETER INTRODUCER. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Datascope Corp. (Oakland, US). The FDA issued a Cleared decision on June 26, 1990, 92 days after receiving the submission on March 26, 1990.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K901391 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 1990 |
| Decision Date | June 26, 1990 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | DYB - Introducer, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1340 |