The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corporation with the FDA for One Way Soft Valve.
| Device ID | K142500 |
| 510k Number | K142500 |
| Device Name: | One Way Soft Valve |
| Classification | Cpb Check Valve, Retrograde Flow, In-line |
| Applicant | Terumo Cardiovascular Systems Corporation 28 Howe Street Ashland, MA 01721 |
| Contact | Suzanne Grenier |
| Correspondent | Suzanne Grenier Terumo Cardiovascular Systems Corporation 28 Howe Street Ashland, MA 01721 |
| Product Code | MJJ |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-05 |
| Decision Date | 2015-01-29 |
| Summary: | summary |