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510(k) K141275

ENDOPHYS PRESSURE SENSING SHEATH KIT by Endophys, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2015
Date Received
May 16, 2014
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

Other clearances by Endophys, Inc.

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  • K141615 — ENDOPHYS BLOOD PRESSURE MONITOR (January 7, 2015)

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