ARTASSIST AND VENASSIST— 510(k) K131146
Substantially EquivalentAci Medical, LLC
FDA 510(k) clearance K131146 for ARTASSIST AND VENASSIST, Substantially Equivalent on 2014-02-10. Applicant: Aci Medical, LLC. Device class: 2.
Clearance details
- Applicant
- Aci Medical, LLC
- Product code
- Code JOW
- Device class
- Class 2
- Regulation
- 21 CFR 870.5800
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Marcos, CA, US
Recent devices under product code JOW
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