510(k) K142500
K142500 is an FDA 510(k) premarket notification submitted by Terumo Cardiovascular Systems Corporation for the device "One Way Soft Valve". The FDA issued a decision of Substantially Equivalent on January 29, 2015. The device falls under product code MJJ (Cpb Check Valve, Retrograde Flow, In-Line), a Class II device regulated under 21 CFR 870.4400. Terumo Cardiovascular Systems Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 2015
- Date Received
- September 5, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cpb Check Valve, Retrograde Flow, In-Line
- Device Class
- Class II
- Regulation Number
- 870.4400
- Review Panel
- CV
- Submission Type