K895542 is an FDA 510(k) clearance for the SONICATH(TM) 5 F. 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 April 6, 1990, 205 days after receiving the submission on September 13, 1989.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K895542 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 1989 |
| Decision Date | April 06, 1990 |
| Days to Decision | 205 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 |