K182442 is an FDA 510(k) clearance for the MiniGuard Arterial Safety Valve. This device is classified as a Cpb Check Valve, Retrograde Flow, In-line (Class II - Special Controls, product code MJJ).
Submitted by Quest Medical, Inc. (Allen, US). The FDA issued a Cleared decision on November 6, 2018, 60 days after receiving the submission on September 7, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4400.
| 510(k) Number | K182442 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 2018 |
| Decision Date | November 06, 2018 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MJJ — Cpb Check Valve, Retrograde Flow, In-line |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4400 |