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510(k) K964238

AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS by Aircast, Inc. — Product Code JOW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1997
Date Received
October 23, 1996
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)
  • K023800 — VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, MODE (February 10, 2003)
  • K992454 — VENAFLOW SYSTEM, MODEL 30A (January 13, 2000)
  • 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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