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510(k) K202874

Puritan Bennett Cuff Pressure Manager by Covidien, LLC — Product Code BSK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2021
Date Received
September 28, 2020
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

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Other clearances for product code BSK

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  • K192611 — Cuffix (August 13, 2020)
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  • 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)