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510(k) K213577

VenAir, Sequential Compression System by Apex Medical Corp. — Product Code JOW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2022
Date Received
November 10, 2021
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 Apex Medical Corp.

  • K193206 — WiZARD 510 Nasal Mask (October 29, 2020)
  • K182394 — WiZARD 310/320 Series CPAP Mask (May 17, 2019)
  • K150111 — Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series (September 15, 2015)
  • K141522 — APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES (October 6, 2014)
  • K121642 — WIZARD 230 NASAL PILOW MASK (June 6, 2013)
  • K112079 — APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720 (December 6, 2012)
  • K120035 — APEX MEDICAL ICH CPAP SERIES (9S-007XXX) (May 16, 2012)
  • K103174 — APEX MEDICAL WIZARD SERIES CPAP MASK (May 6, 2011)
  • K103535 — VACPLUS SUCTION UNIT (February 24, 2011)
  • K083656 — APEX MEDICAL XT AUTO CPAP 9S-005200 (April 22, 2009)

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)