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510(k) K992123

SCIMED IMPULSE ANGIOGRAPHIC CATHETERS by Boston Scientific Scimed, Inc. — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 1999
Date Received
June 23, 1999
Clearance Type
Traditional
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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  • 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)

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