K922573 is an FDA 510(k) clearance for the 10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE. 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 8, 1992, 190 days after receiving the submission on June 1, 1992.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K922573 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 1992 |
| Decision Date | December 08, 1992 |
| Days to Decision | 190 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MAV — Syringe, Balloon Inflation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1650 |