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510(k) K980113

WALLSTENT ENTERAL ENDOPROSTHESIS by Boston Scientific Scimed, Inc. — Product Code MUM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1998
Date Received
January 13, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Boston Scientific Scimed, Inc.

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  • K024048 — MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM (January 6, 2003)
  • K021735 — BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER (August 8, 2002)
  • K021901 — WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (July 9, 2002)
  • K012822 — MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, (October 24, 2001)
  • K012216 — NIROYAL BILIARY PREMOUNTED STENT SYSTEM (August 17, 2001)
  • K000743 — BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020 (September 6, 2000)
  • K000001 — WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM (June 5, 2000)
  • K000956 — MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS (April 21, 2000)

Other clearances for product code MUM

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  • K223067 — Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent (June 14, 2023)
  • K163468 — Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Un (May 4, 2017)
  • K101530 — EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-1 (March 29, 2011)
  • K062750 — WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M005650 (December 4, 2006)