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510(k) K912469

BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE by Bivona Medical Technologies — Product Code BTO

K912469 is an FDA 510(k) premarket notification submitted by Bivona Medical Technologies for the device "BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE". The FDA issued a decision of Substantially Equivalent on June 19, 1991. The device falls under product code BTO (Tube, Tracheostomy (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5800. Bivona Medical Technologies has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1991
Date Received
June 4, 1991
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 Bivona Medical Technologies

  • K952700 — SUPERSLICK (October 31, 1995)
  • K942025 — BURGET NASAL STENT (October 27, 1995)
  • K944178 — BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES (October 27, 1994)
  • K935053 — BIVONA NASAL TURBINATE STENT (July 1, 1994)
  • K933398 — BIVONA ILLUMINATED ENDOTRACHEAL TUBE (October 6, 1993)
  • K931749 — BIVONA(R) ICU ENDOTRACHEAL TUBE (August 10, 1993)
  • K922665 — BIVONA HYPERFLEX TRACHEOSTOMY TUBE (January 7, 1993)
  • K923878 — BIVONA CUSTOMIZED TRACHEOSTOMY TUBES (December 29, 1992)
  • K920604 — BIVONA TRACHEAL T-TUBE STENT (July 27, 1992)
  • K915761 — BIVONA-COLORADO VOICE PROSTHESIS (June 29, 1992)

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