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510(k) K982077

SELECTOR DIAGNOSTIC CATHETER by Boston Scientific Scimed, Inc. — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1998
Date Received
June 12, 1998
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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  • 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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