One Way Soft Valve— 510(k) K142500
Substantially EquivalentTerumo Cardiovascular Systems Corporation
FDA 510(k) clearance K142500 for One Way Soft Valve, Substantially Equivalent on 2015-01-29. Applicant: Terumo Cardiovascular Systems Corporation. Device class: 2.
Clearance details
- Applicant
- Terumo Cardiovascular Systems Corporation
- Product code
- Code MJJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.4400
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ashland, MA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.