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510(k) K131146

ARTASSIST AND VENASSIST by Aci Medical, LLC — Product Code JOW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2014
Date Received
April 23, 2013
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 Aci Medical, LLC

  • K942530 — ART-ASSIST MODEL AA-1000 (February 28, 1996)
  • K903894 — VENAPULSE MODELS VP-25 AND VP-50 (April 3, 1991)
  • K903532 — UNNA-SLEEVE(TM) (November 2, 1990)
  • K881291 — AIR PLETHYSMOGRAPH MODEL APG-1000 (October 14, 1988)
  • K861645 — MICRO-TRACHEOSTOMY CARE KIT (May 9, 1986)
  • K844309 — IV RATEMETER (January 22, 1985)

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