K942927 is an FDA 510(k) clearance for the 0.035 IN. WISE WIRE. 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 June 13, 1995, 356 days after receiving the submission on June 22, 1994.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K942927 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 1994 |
| Decision Date | June 13, 1995 |
| Days to Decision | 356 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | DQO — Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |