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510(k) K151951

Destino Reach by Oscor, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2015
Date Received
July 15, 2015
Clearance Type
Special
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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  • K122958 — DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY (December 13, 2012)
  • K122084 — INTRODUCER SET, MODEL ADELANTE-S SERIES (August 29, 2012)

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