K891580 is an FDA 510(k) clearance for the INTRAVASCULAR CATHETER WITH HYDROPHILIC COATING. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on August 3, 1989, 136 days after receiving the submission on March 20, 1989.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K891580 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 1989 |
| Decision Date | August 03, 1989 |
| Days to Decision | 136 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DQO — Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |