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510(k) K142103

CUFF PILOT, SURE SEAL by Teleflexmedical, Inc. — Product Code BSK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2015
Date Received
August 1, 2014
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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  • K181852 — Percuvance Percutaneous Surgical System (October 12, 2018)
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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)