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510(k) K101497

DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY by Oscor, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2010
Date Received
June 1, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

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  • K140406 — DESTINO TWIST, STEERABLE GUIDING SHEATH (April 17, 2014)
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  • K130843 — SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE (January 8, 2014)
  • K130104 — GUIDEWIRE, PURSUER SERIES (June 13, 2013)
  • K122960 — STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO (December 13, 2012)
  • K122958 — DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY (December 13, 2012)

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