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510(k) K022067

CONVOY ADVANCED DELIVERY SHEATH by Boston Scientific — Product Code DBY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2002
Date Received
June 25, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fab, Rhodamine, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5520
Review Panel
IM
Submission Type

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Other clearances for product code DBY

  • K013919 — TORFLEX TRANSSEPTAL GUIDING SHEATH (February 22, 2002)
  • K013304 — BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER (January 2, 2002)
  • K013282 — GORE INTRODUCER SHEATH (December 14, 2001)
  • K013866 — CONVOY ADVANCED DELIVERY SHEATH KIT (December 14, 2001)
  • K771144 — RHODAMINE-CONJUGATED ANTISERUM (July 14, 1977)