K904394 is an FDA 510(k) clearance for the INFLATION/DEFLATION DEVICE. This device is classified as a Syringe, Balloon Inflation (Class II - Special Controls, product code MAV).
Submitted by Boston Scientific Corp (San Jose, US). The FDA issued a Cleared decision on December 3, 1990, 69 days after receiving the submission on September 25, 1990.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K904394 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 1990 |
| Decision Date | December 03, 1990 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | MAV — Syringe, Balloon Inflation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1650 |