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510(k) K000956

MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS by Boston Scientific Scimed, Inc. — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2000
Date Received
March 24, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

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

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