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510(k) K131571

AVD RIGHT RADIAL DRAPE by Advanced Vascular Dynamics — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2014
Date Received
May 30, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drape, Surgical
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

Other clearances by Advanced Vascular Dynamics

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  • K142122 — RADAR VASCULAR COMPRESSION DEVICE (December 4, 2014)
  • K093192 — FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICE (February 12, 2010)
  • K092503 — RADAR VASCULAR COMPRESSION DEVICES (November 19, 2009)
  • K090286 — PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE (March 23, 2009)
  • K072167 — COMFORTPRESS VASCULAR COMPRESSION ASSIST DEVICE (September 6, 2007)
  • K040615 — COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM (June 1, 2004)

Other clearances for product code KKX

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  • K222578 — 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) (May 18, 2023)
  • K202208 — BeneHold Surgical Incise Drape with CHG antimicrobial (July 30, 2021)
  • K200238 — ControlRad Sterile Cover (April 26, 2020)
  • K163556 — MediClear PreOp (September 14, 2017)
  • K133080 — Plus Surgical Drapes (EO Sterilized), PMDB-XXX (June 24, 2015)
  • K141324 — HONGYU DISPOSABLE SURGICAL DRAPES (April 14, 2015)
  • K140195 — SURGICAL DRAPE (September 10, 2014)
  • K140330 — 3M STERI-DRAPE FABRIC SURGICAL DRAPES (August 18, 2014)
  • K141438 — WHITNEY MEDICAL SOLUTIONS ESHIELD (August 14, 2014)