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510(k) K895130

HEIMLICH MICRO TRACH by Ballard Medical Products — Product Code BTO

K895130 is an FDA 510(k) premarket notification submitted by Ballard Medical Products for the device "HEIMLICH MICRO TRACH". The FDA issued a decision of Substantially Equivalent on November 7, 1989. The device falls under product code BTO (Tube, Tracheostomy (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5800. Ballard Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1989
Date Received
August 17, 1989
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 Ballard Medical Products

  • K030721 — QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE (March 31, 2003)
  • K022398 — REUSABLE BRONCHIAL BIOPSY FORCEPS (October 11, 2002)
  • K013892 — LUTZ NEEDLE (July 11, 2002)
  • K000495 — BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES (March 28, 2000)
  • K993138 — BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT (October 20, 1999)
  • K990376 — BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME (May 3, 1999)
  • K982894 — MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT (September 11, 1998)
  • K974630 — 72 HOUR USE TRACH CARE WITH MICROBAN (March 11, 1998)
  • K964369 — TRACH CARE SET WITH MICROBAN (February 11, 1997)
  • K951533 — EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT (July 5, 1995)

Other clearances for product code BTO

  • K253063 — Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 S (September 11, 2026)
  • 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)

FDA data resources