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510(k) K810321

REINFORCED TRACHEOSTOMY TUBE SET(TENTAT) by National Catheter Co. Div. Mallinckrodt — Product Code BTO

K810321 is an FDA 510(k) premarket notification submitted by National Catheter Co. Div. Mallinckrodt for the device "REINFORCED TRACHEOSTOMY TUBE SET(TENTAT)". The FDA issued a decision of Substantially Equivalent on March 4, 1981. The device falls under product code BTO (Tube, Tracheostomy (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5800. National Catheter Co. Div. Mallinckrodt has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1981
Date Received
February 6, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheostomy (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5800
Review Panel
AN
Submission Type

Other clearances by National Catheter Co. Div. Mallinckrodt

  • K802918 — ANTHRON CATHETER SET (April 21, 1981)
  • K802505 — DOUBLE LUMEN TRACHEAL TUBE (March 13, 1981)
  • K801924 — HI-LO TEMP GEN. PURPOSE TEMP. PROBE (September 9, 1980)
  • K801005 — MLT TUBE MICROLARYNGEAL TRACHEAL TUBE) (May 23, 1980)
  • K791190 — STETHOSCOPE WITH TEMPERATURE SENSOR (July 6, 1979)
  • K781665 — TUBE, LEATHERMAN/IMBRUCE (December 15, 1978)
  • K770727 — MANIPULATOR & INJECTOR, UTERINE (April 26, 1977)

Other clearances for product code BTO

  • K242921 — 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes (June 10, 2025)
  • K233713 — Pilling Tracheostomy Tubes (March 22, 2024)
  • K192511 — Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy (July 22, 2020)
  • K173384 — BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestr (April 10, 2018)
  • K120079 — PRIMED TRACHEOSTOMY TUBES (MULTIPLE) (May 24, 2012)
  • K101721 — WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA (March 24, 2011)
  • K100950 — VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE (July 13, 2010)
  • K100480 — ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH (June 11, 2010)
  • K100283 — VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PRE (April 23, 2010)
  • K083031 — PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT (August 18, 2009)

FDA data resources