Home / 510(k) Clearances / K140097

510(k) K140097

AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM by Applied Medical Technology, Inc. — Product Code CBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2014
Date Received
January 14, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Fixation, Tracheal Tube
Device Class
Class I
Regulation Number
868.5770
Review Panel
AN
Submission Type

Other clearances by Applied Medical Technology, Inc.

  • K252438 — Explant Express (February 3, 2026)
  • K240514 — AMT Low-Profile Suprapubic Catheter & Drainage Set (November 1, 2024)
  • K241111 — AMT Suture Passer (July 5, 2024)
  • K222846 — AMT G-Tube Balloon Gastrostomy Feeding Device (December 18, 2023)
  • K202539 — Nutriglide(TM) Nasal Feeding Tube (October 29, 2020)
  • K193612 — AMT Suture Delivery System (March 12, 2020)
  • K183508 — Micro Transgastric-Jejunal Feeding Device (March 29, 2019)
  • K182804 — Traditional Length GJ Feeding Device (March 1, 2019)
  • K180026 — Bowel Management Device, Bowel Management Irrigation Set (June 1, 2018)
  • K170319 — Low Profile Non-Balloon Feeding Device (October 6, 2017)

Other clearances for product code CBH

  • K964399 — DALE ENDOTRACHEAL TUBE HOLDER 270/280 (January 28, 1997)
  • K942529 — HCI TUBE STABILIZER (June 14, 1995)
  • K951491 — DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS (April 24, 1995)
  • K950930 — TRACHE-TITE (March 22, 1995)
  • K950318 — FLEX BLUE (February 13, 1995)
  • K942395 — ENDOTRACHEAL TUBE HOLDER (June 30, 1994)
  • K934288 — HOLDE.T. ENDOTRACHEAL TUBE STABILIZATION BAR (June 9, 1994)
  • K942016 — TRACH TIE, VENTILATOR TUBING HOLDER (May 24, 1994)
  • K941384 — TRAKEEZ (April 19, 1994)
  • K940448 — NETOH ENDOTRACHEAL TUBE HOLDER (February 22, 1994)