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510(k) K873499

TODD MEDICAL/SKILLED CARE PRODUCTS by Todd Medical, Inc. — Product Code BTO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1987
Date Received
August 31, 1987
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 Todd Medical, Inc.

  • K873288 — CLOSED FOLEY CATHETER SYSTEM (November 27, 1987)
  • K873287 — IRRIGATION TRAY (W/120CC OF STERILE NORMAL SALINE) (November 13, 1987)
  • K873469 — TODD MEDICAL/SKILLED CARE PRODUCTS (October 29, 1987)
  • K850646 — ECLIPSE SELF ADHERING ELECTRODE (September 3, 1985)
  • K850004 — TRANSCUTANEOUS NERVE STIMULATOR FOR PAIN RELIEF (April 2, 1985)

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)