K142500 is an FDA 510(k) clearance for the One Way Soft Valve. This device is classified as a Cpb Check Valve, Retrograde Flow, In-line (Class II - Special Controls, product code MJJ).
Submitted by Terumo Cardiovascular Systems Corporation (Ashland, US). The FDA issued a Cleared decision on January 29, 2015, 146 days after receiving the submission on September 5, 2014.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4400.
| 510(k) Number | K142500 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 2014 |
| Decision Date | January 29, 2015 |
| Days to Decision | 146 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 |