K890800 is an FDA 510(k) clearance for the ROTATING HEMOSTATIC VALVE. This device is classified as a Catheter, Angioplasty, Peripheral, Transluminal (Class II - Special Controls, product code LIT).
Submitted by Datascope Corp. (Oakland, US). The FDA issued a Cleared decision on June 12, 1989, 116 days after receiving the submission on February 16, 1989.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K890800 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 16, 1989 |
| Decision Date | June 12, 1989 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | LIT - Catheter, Angioplasty, Peripheral, Transluminal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |