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510(k) K180389

Venera 508 Deep Vein Thrombosis (DVT) Prevention System by Suzhou Minhua Medical Apparatus Supplies Co., Ltd. — Product Code JOW

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

Other clearances by Suzhou Minhua Medical Apparatus Supplies Co., Ltd.

  • K241096 — Venera 608 Deep Vein Thrombosis (DVT) Prevention System (January 15, 2025)
  • K233276 — Reusable Blood Pressure Cuff (December 21, 2023)
  • K171889 — Reusable Blood Pressure Cuff (December 19, 2017)

Other clearances for product code JOW

  • K254267 — NanoPress 760A-BT (760A-BT) (February 24, 2026)
  • K250974 — Bio Arterial Deluxe (IC-BAP-DX) (December 12, 2025)
  • K250190 — Sequential Compression System (SCD600) (December 8, 2025)
  • K251466 — VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compressio (October 28, 2025)
  • K251446 — PlasmaFlow X Compression Sleeve Device (XPF0001) (September 17, 2025)
  • K251086 — PnueAira (PNCU-01) (August 18, 2025)
  • K250817 — Coretech Compression System (Coretech RHB3003) (August 8, 2025)
  • K241096 — Venera 608 Deep Vein Thrombosis (DVT) Prevention System (January 15, 2025)
  • K240499 — ARTAIRA Arterial Compression Device (AACD01) (October 11, 2024)
  • K241746 — UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSED KENDALL SCD EXPRES (October 4, 2024)