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510(k) K990504

MEMOTHERM COLORECTAL STENT by C.R. Bard, Inc. — Product Code MQR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2000
Date Received
February 17, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stent, Colonic, Metallic, Expandable
Device Class
Class II
Regulation Number
878.3610
Review Panel
GU
Submission Type

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  • K190141 — HANAROSTENT LowAx Colon/Rectum (NNN) (March 7, 2019)
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  • K180180 — HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NN (November 2, 2018)
  • K113510 — EVOLUTION COLONIC STENT SYSTEM (May 17, 2012)
  • K061877 — WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM (September 15, 2006)
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  • K042065 — WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM (September 30, 2004)