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510(k) K023800

VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, MODEL 3017 by Aircast, Inc. — Product Code JOW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2003
Date Received
November 14, 2002
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 Aircast, Inc.

  • K024019 — ARTERIALFLOW SYSTEM, MODEL 32A (June 3, 2003)
  • K992454 — VENAFLOW SYSTEM, MODEL 30A (January 13, 2000)
  • K964238 — AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS (September 8, 1997)
  • K961676 — AIRCAST VENAFLOW SYSTEM (MODIFICATION) (March 28, 1997)
  • K933977 — AIRCAST EDEMAFLOW SYSTEM (December 7, 1993)
  • K932900 — AIRCAST VENAFLOW SYSTEM (October 25, 1993)
  • K925677 — AUTOCHILL ACCESSORY KIT (April 14, 1993)
  • K812094 — AIRCAST PNEUMATIC KNEE BRACE (August 13, 1981)
  • K810288 — AIRCAST TENNIS ARM BAND (February 12, 1981)
  • K780979 — AIRSTIRRUP PNEUMATIC ANKLE BRACE (June 30, 1978)

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