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510(k) K111662

VENOTRAIN CURAFLOW by Bauerfeind AG — Product Code DWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2011
Date Received
June 14, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
Device Class
Class II
Regulation Number
880.5780
Review Panel
HO
Submission Type

Other clearances by Bauerfeind AG

  • K123921 — BODYTRONIC 200 (April 26, 2013)

Other clearances for product code DWL

  • K141127 — MEDLINE ANTI-EMBOLISM STOCKING (August 21, 2014)
  • K131496 — BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE) (July 10, 2013)
  • K122485 — ENCIRCLE COMPRESSION THERAPY STOCKING (April 23, 2013)
  • K123820 — BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EM (April 2, 2013)
  • K123085 — FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOC (December 20, 2012)
  • K123561 — ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS (December 18, 2012)
  • K123398 — DR. SCHOLL'S COMPRESSION SOCKS (December 18, 2012)
  • K121106 — TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION G (April 27, 2012)
  • K112769 — CURAD COMPRESSION HOSIERY (March 1, 2012)
  • K101614 — HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809 (January 13, 2011)