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510(k) K190098

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2019
Date Received
January 22, 2019
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

  • K180620 — Endophys Pressure Sensing Sheath Kit (October 12, 2018)
  • K173399 — Endophys Pressure Sensing Sheath Kit- 8F (November 30, 2017)
  • K160945 — Endophys Blood Pressure Monitor (September 26, 2016)

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