510(k) K180389
K180389 is an FDA 510(k) premarket notification submitted by Suzhou Minhua Medical Apparatus Supplies Co., Ltd. for the device "Venera 508 Deep Vein Thrombosis (DVT) Prevention System". The FDA issued a decision of Substantially Equivalent on June 29, 2018. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Suzhou Minhua Medical Apparatus Supplies Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 29, 2018
- Date Received
- February 13, 2018
- 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