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510(k) K160272

Endophys Pressure Sensing Sheath Kit by Endophys, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2016
Date Received
February 2, 2016
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

Other clearances by Endophys, Inc.

  • K141275 — ENDOPHYS PRESSURE SENSING SHEATH KIT (January 7, 2015)
  • K141615 — ENDOPHYS BLOOD PRESSURE MONITOR (January 7, 2015)

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