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510(k) K243562

CuffGuard by Idmed — Product Code BSK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2025
Date Received
November 18, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cuff, Tracheal Tube, Inflatable
Device Class
Class II
Regulation Number
868.5750
Review Panel
AN
Submission Type

Other clearances by Idmed

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  • K172690 — ToFscan (May 31, 2018)

Other clearances for product code BSK

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  • K220854 — TrachCuff Cuff Controller (April 14, 2023)
  • K221477 — AG100s (December 29, 2022)
  • K202874 — Puritan Bennett Cuff Pressure Manager (January 9, 2021)
  • K192611 — Cuffix (August 13, 2020)
  • K191858 — Pylant Monitor (February 24, 2020)
  • K182548 — Accucuff Cuff Pressure Indicator (January 25, 2019)
  • K180991 — AG 100s (October 12, 2018)
  • K173914 — VORTRAN Cuff Inflator (VCI) (May 25, 2018)
  • K152778 — TRACOE Cuff Pressure Monitor (December 21, 2016)