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Panels › Anesthesiology › Product code BTO · Class 2

Tube, Tracheostomy (W/Wo Connector)

Regulation 868.5800

1510(k)s in 12 months (129 all time)
1recalls in 12 months (73 all time)
69recalls that name a 510(k)
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Top companies in BTO

DateFirm and productCodeLinked 510(k)
Jan 19, 2012Smiths Medical ASD, Inc.
Bivona Uncuffed Neonatal Flex Tend Plus Tracheostomy Tube Sizes 2.5 - 4.0 (With a V-Shaped Neck Flange) Product Usage: This tube is intended to provide direct airway access for a tracheostomized p
Terminated
BTOK912469
Jan 19, 2012Smiths Medical ASD, Inc.
Bivona Aire-Cuf Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocesse
Terminated
BTOK912469
Jan 19, 2012Smiths Medical ASD, Inc.
Bivona Aire-Cuf Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocesse
Terminated
BTOK912469
Jan 19, 2012Smiths Medical ASD, Inc.
Bivona TTS Cuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a V-Shaped Neck Flange).
Terminated
BTOK912469
Jan 19, 2012Smiths Medical ASD, Inc.
Bivona TTS Cuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a Straight Neck Flange) Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up
Terminated
BTOK912469
Jun 28, 2011VBM Medical Inc.
Jet-Ventilator Catheter for Adults, 14G, STERILE, NO LATEX, REF 30-02-918-1, VBM Medizintechnik GmbH, Einsteinstrasse 1 7212 Sul z a.N. Germany Allows a safe and atraumatic transtracheal access for o
Terminated
BTOK955461
Jun 28, 2011VBM Medical Inc.
Jet-Ventilator Catheter for Adults, 14G, STERILE, NO LATEX, REF 30-02-914-1, VBM Medizintechnik GmbH, Einsteinstrasse 1 7212 Sulz a.N. Germany Allows a safe and atraumatic transtracheal access for ox
Terminated
BTOK955461
Jun 24, 2011Arcadia Medical Corporation
Silicone CTS (Close to Shaft) Cuff Adjustable Neck Flange Tracheostomy Tube (Wire Reinforced), Arcadia Medical Silicone Air Cuff Adjustable Tracheostomy Tube, Sterile, Latex-Free, Provides direct tr
Terminated
BTOK031553
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Single Cannula Cuffed Tracheostomy Tube, 10 SCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructio
Terminated
BTOK810106
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Single Cannula Cuffed Tracheostomy Tube, 9 SCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstruction
Terminated
BTOK810106
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Single Cannula Cuffed Tracheostomy Tube, 8 SCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstruction
Terminated
BTOK810106
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Single Cannula Cuffed Tracheostomy Tube, 7 SCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstruction
Terminated
BTOK810106
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Single Cannula Cuffed Tracheostomy Tube, 6 SCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstruction
Terminated
BTOK810106
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Single Cannula Cuffed Tracheostomy Tube, 5 SCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstruction
Terminated
BTOK810106
Nov 9, 2009Gf Health Products, Inc.
John Bunn 1392 Series Jackson Tracheostomy Stainless Steel Tube.
Terminated
BTONone listed
Sep 3, 2009Instrumentation Industries Inc
Transtracheal (Jet Ventilation) Catheter ACU 1060.1, labeled sterile if unopened. The Jet Ventilation Catheter allows a safe and atraumatic transtracheal access for oxygenation/ventilation.
Terminated
BTOK955461
Apr 6, 2006Smiths Medical ASD, Inc.
Blue Line Ultra Tracheostomy Tube 8.00mm Inner Cannula REF 100/858/080
Terminated
BTOK030381
Jan 6, 2006Smiths Medical ASD, Inc.
Bivona brand Cuffless Extra Length Fixed Hyperflex Adult Tracheostomy Tube, 110 mm, sterile, Product code 60AFHXL70.
Terminated
BTOK922665
Dec 23, 2005Smiths Medical ASD, Inc.
Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, product code 67N040.
Terminated
BTOK914088
Dec 23, 2005Smiths Medical ASD, Inc.
Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tubes, sterile, Product 67HA70.
Terminated
BTOK894614
Nov 24, 2004Smiths Medical ASD, Inc.
Portex Lo-Profile Tracheostomy Tube Decannulation Cap Catalog Number: 582000
Terminated
BTOK922749
K934465
Nov 24, 2004Smiths Medical ASD, Inc.
Portex Tracheostomy Tube Decannulation Cap for use only with Fenestrated Tracheostomy Tubes Catalog Number: 519000
Terminated
BTOK922749
K934465
Jul 23, 2003Portex Inc.
Lo-Profile Fenestrated Tracheostomy Tube, Cuffed and Fenestrated Tube I.D. 9.0mm Catalog Number: 593090
Terminated
BTOK922749

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