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510(k) K122958

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2012
Date Received
September 25, 2012
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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  • K130104 — GUIDEWIRE, PURSUER SERIES (June 13, 2013)
  • K122960 — STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO (December 13, 2012)
  • K122084 — INTRODUCER SET, MODEL ADELANTE-S SERIES (August 29, 2012)

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