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)
Top companies in BTO
| Company | 510(k)s | Recalls |
|---|---|---|
| Smiths Medical Asd, Inc. | 1 | 55 |
| Shiley, Inc. | 13 | 0 |
| Bivona Medical Technologies | 6 | 0 |
| Nellcor Puritan Bennett Inc. (dba Covidien Ltd) | 0 | 6 |
| American Healthcare Corp. | 5 | 0 |
| Frederic J. Toye, M.D. | 5 | 0 |
| Hood Laboratories | 4 | 0 |
| Portex , Ltd. | 3 | 1 |
| Arcadia Medical Corporation | 1 | 2 |
| Boston Medical Products, Inc. | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 19, 2012 | Smiths 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 |
BTO | K912469 |
| Jan 19, 2012 | Smiths 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 |
BTO | K912469 |
| Jan 19, 2012 | Smiths 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 |
BTO | K912469 |
| Jan 19, 2012 | Smiths Medical ASD, Inc. Bivona TTS Cuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a V-Shaped Neck Flange). Terminated |
BTO | K912469 |
| Jan 19, 2012 | Smiths 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 |
BTO | K912469 |
| Jun 28, 2011 | VBM 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 |
BTO | K955461 |
| Jun 28, 2011 | VBM 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 |
BTO | K955461 |
| Jun 24, 2011 | Arcadia 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 |
BTO | K031553 |
| May 6, 2010 | Nellcor 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 |
BTO | K810106 |
| May 6, 2010 | Nellcor 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 |
BTO | K810106 |
| May 6, 2010 | Nellcor 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 |
BTO | K810106 |
| May 6, 2010 | Nellcor 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 |
BTO | K810106 |
| May 6, 2010 | Nellcor 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 |
BTO | K810106 |
| May 6, 2010 | Nellcor 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 |
BTO | K810106 |
| Nov 9, 2009 | Gf Health Products, Inc. John Bunn 1392 Series Jackson Tracheostomy Stainless Steel Tube. Terminated |
BTO | None listed |
| Sep 3, 2009 | Instrumentation 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 |
BTO | K955461 |
| Apr 6, 2006 | Smiths Medical ASD, Inc. Blue Line Ultra Tracheostomy Tube 8.00mm Inner Cannula
REF 100/858/080 Terminated |
BTO | K030381 |
| Jan 6, 2006 | Smiths Medical ASD, Inc. Bivona brand Cuffless Extra Length Fixed Hyperflex Adult Tracheostomy Tube, 110 mm, sterile, Product code 60AFHXL70. Terminated |
BTO | K922665 |
| Dec 23, 2005 | Smiths Medical ASD, Inc. Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, product code 67N040. Terminated |
BTO | K914088 |
| Dec 23, 2005 | Smiths Medical ASD, Inc. Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tubes, sterile, Product 67HA70. Terminated |
BTO | K894614 |
| Nov 24, 2004 | Smiths Medical ASD, Inc. Portex Lo-Profile Tracheostomy Tube Decannulation Cap
Catalog Number: 582000 Terminated |
BTO | K922749 K934465 |
| Nov 24, 2004 | Smiths Medical ASD, Inc. Portex Tracheostomy Tube Decannulation Cap for use only with Fenestrated Tracheostomy Tubes
Catalog Number: 519000 Terminated |
BTO | K922749 K934465 |
| Jul 23, 2003 | Portex Inc. Lo-Profile Fenestrated Tracheostomy Tube, Cuffed and Fenestrated Tube I.D. 9.0mm
Catalog Number: 593090 Terminated |
BTO | K922749 |
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