FDA.report

510(k) K233713

Device
Pilling Tracheostomy Tubes
Applicant
Teleflex Medical
510(k) number
K233713
Product code
BTO
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-22
Date received
2023-11-20
Regulation
868.5800
Classification name
Tube, Tracheostomy (W/Wo Connector)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Hannah Boning
Address
3015 Carrington Mill Blvd. Morrisville NC US 27560 27560

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code BTO

510(k)DeviceApplicantDecision date
K2429215300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mmVitaltec Corporation2025-06-10
K192511Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mmVenner Medical (Singapore) Pte, Ltd.2020-07-22
K173384BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tubeSmiths Medical Ads, Inc.2018-04-10
K120079PRIMED TRACHEOSTOMY TUBES (MULTIPLE)Primed Halberstadt Medizintechnik GmbH2012-05-24
K101721WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULARegulatory and Marketing Services, Inc.2011-03-24
K100950VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBEVenner Medical (Singapore) Pte, Ltd.2010-07-13
K100480ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACHVitaltec Corporation2010-06-11
K100283VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTICCook, Inc.2010-04-23
K083031PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KITSmiths Medical Asd, Inc.2009-08-18
K073702PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTORLazarus Medical, LLC2008-06-26
K062104TALKING TRACHEngineered Medical Systems, Inc.2007-04-20
K060945PORTEX PERCUTANEOUS TRACHEOSTOMY KITSmiths Medical International2006-06-19
K051587TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470Tracoe Medical GmbH2005-10-25
K050379CS MEDICAL ADULT TTCF CATHETERCs Medical, Inc.2005-07-12
K042684WELL LEAD TRACHEOSTOMY TUBEWell Lead Medical Instruments2005-02-17