510(k) K131146
K131146 is an FDA 510(k) premarket notification submitted by Aci Medical, LLC for the device "ARTASSIST AND VENASSIST". The FDA issued a decision of Substantially Equivalent on February 10, 2014. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Aci Medical, LLC has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 2014
- Date Received
- April 23, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sleeve, Limb, Compressible
- Device Class
- Class II
- Regulation Number
- 870.5800
- Review Panel
- CV
- Submission Type