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510(k) K180620

Endophys Pressure Sensing Sheath Kit by Endophys Holdings, LLC — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 2018
Date Received
March 9, 2018
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 Holdings, LLC

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  • K173399 — Endophys Pressure Sensing Sheath Kit- 8F (November 30, 2017)
  • K160945 — Endophys Blood Pressure Monitor (September 26, 2016)

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