Home / 510(k) Clearances / K961977

510(k) K961977

KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE by Kendall Healthcare Products Co. Div.Of Tyco Health — Product Code CBI

K961977 is an FDA 510(k) premarket notification submitted by Kendall Healthcare Products Co. Div.Of Tyco Health for the device "KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE". The FDA issued a decision of Substantially Equivalent on July 31, 1996. The device falls under product code CBI (Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5740. Kendall Healthcare Products Co. Div.Of Tyco Health has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1996
Date Received
May 20, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5740
Review Panel
AN
Submission Type

Other clearances by Kendall Healthcare Products Co. Div.Of Tyco Health

  • K973763 — KENDALL CURITY IODOFORM PACKING STRIP (December 31, 1997)
  • K973511 — KENDALL CURITY PETROLATUM GAUZE (December 16, 1997)
  • K973507 — KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317) (December 15, 1997)
  • K973619 — KENDALL CURITY NON-ADHERING DRESSING (December 10, 1997)
  • K973509 — KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING (December 4, 1997)
  • K973546 — KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER (November 7, 1997)
  • K970266 — KENDALL HYDROPHILIC POWDER WOUND DRESSING (April 23, 1997)
  • K963446 — KENDALL DUAL LUMEN CATHETER (March 18, 1997)
  • K964899 — KENDALL CURITY URETERAL CATHETER (February 7, 1997)
  • K964519 — CURITY THORACENTESIS TRAY (December 20, 1996)

Other clearances for product code CBI

  • K251950 — Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endo (March 20, 2026)
  • K253096 — Chartis Precision Catheter (February 13, 2026)
  • K232529 — Disposable Double Lumen Endobronchial Tube (May 13, 2024)
  • K232580 — Disposable Endobronchial Blocker Tube (December 14, 2023)
  • K222340 — Chartis Precision Catheter (December 1, 2022)
  • K201026 — sOLVe Tube (August 10, 2021)
  • K203749 — Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable (May 3, 2021)
  • K200968 — ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R (December 28, 2020)
  • K181886 — VivaSight-DL System (November 14, 2018)
  • K180253 — Sheridan Endobronchial Tubes (November 2, 2018)

FDA data resources