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510(k) K012612

CLEARMEDICAL/NOVAMEDIX AVI FOOT COVER, PAIR, REGULAR & LARGE SIZE by Clearmedical, Inc. — Product Code JOW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2002
Date Received
August 13, 2001
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 Clearmedical, Inc.

  • K033578 — REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS (July 11, 2005)
  • K033579 — REPROCESSED MULTIPLE CLIP APPLIERS (July 11, 2005)
  • K033591 — REPROCESSED TROCARS (June 3, 2005)
  • K033592 — REPROCESSED SURGICAL SCISSORS AND GRASPERS (July 27, 2004)
  • K033593 — REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS (November 20, 2003)
  • K031416 — CLEARMEDICAL/CRITIKON BLOOD PRESSURE CUFF; CLEARMEDICAL/WELCH ALLYN BLOOD PRESSU (July 15, 2003)
  • K012600 — CLEARMEDICAL/NELLCOR OXISENSOR II, ADULT, MODEL D-25/D-25L (July 3, 2002)
  • K012609 — CLEARMEDICAL/NELLCOR OXISENSOR II, NEONATAL/ADULT, MODEL N-25 (July 3, 2002)
  • K012622 — CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20 (July 3, 2002)
  • K012616 — CLEARMEDICAL/HUNTLEIGH FOOT GARMENTS; MODELS FG200/LRG (LARGE), FG200/STD (STAND (February 6, 2002)

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  • 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)