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510(k) K013866

CONVOY ADVANCED DELIVERY SHEATH KIT by Boston Scientific — Product Code DBY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2001
Date Received
November 21, 2001
Clearance Type
Special
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

  • K022067 — CONVOY ADVANCED DELIVERY SHEATH (September 11, 2002)
  • 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)
  • K771144 — RHODAMINE-CONJUGATED ANTISERUM (July 14, 1977)