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510(k) K024048

MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM by Boston Scientific Scimed, Inc. — Product Code FGE

Clearance Details

Decision
SESU ()
Decision Date
January 6, 2003
Date Received
December 9, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stents, Drains And Dilators For The Biliary Ducts
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type

Other clearances by Boston Scientific Scimed, Inc.

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  • 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)
  • K993232 — WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM (December 30, 1999)

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