Panels › Anesthesiology › Product code BTR · Class 2
Tube, Tracheal (W/Wo Connector)
Regulation 868.5730
2510(k)s in 12 months (242 all time)
1recalls in 12 months (227 all time)
203recalls that name a 510(k)
Top companies in BTR
| Company | 510(k)s | Recalls |
|---|---|---|
| Teleflex Incorporated | 1 | 127 |
| Teleflex Medical | 2 | 48 |
| Smiths Medical | 0 | 17 |
| Smiths Medical Asd, Inc. | 2 | 10 |
| Sheridan Catheter Corp. | 11 | 0 |
| Mallinckrodt Critical Care | 10 | 0 |
| Rusch, Inc. | 10 | 0 |
| Bivona Medical Technologies | 8 | 0 |
| Covidien | 6 | 1 |
| Polamedco, Inc. | 7 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 28, 2009 | K082038 | CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V Clarus Medical, LLC | BTR |
| Apr 3, 2009 | K090352 | TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES Covidien | BTR |
| Feb 13, 2009 | K080105 | ENDOTRACHEAL TUBE Chilecom Medical Devices Co., Ltd. | BTR |
| Oct 27, 2008 | K080339 | MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF) Medsource International, LLC | BTR |
| Oct 8, 2008 | K082420 | TRACHEOSCOPIC VENTILATION TUBE (TVT) Etview, IL | BTR |
| Oct 2, 2008 | K082520 | SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES Mallinckrodt Medical | BTR |
| Aug 13, 2008 | K081086 | PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE, SIZE 6.0 AND 6.5, 7.0 AND 7.5, 8.0 AND 8.5, 9.0 Smiths Medical Asd, Inc., GB | BTR |
| Jul 10, 2008 | K073383 | WELL LEAD REINFORCED ENDOTRACHEAL TUBE Well Lead Medical Instruments | BTR |
| Apr 22, 2008 | K080821 | MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE Kimberly-Clark Corp. | BTR |
| Mar 25, 2008 | K080170 | AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP) C.R. Bard, Inc. | BTR |
| Nov 6, 2007 | K071365 | AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE C.R. Bard, Inc. | BTR |
| May 8, 2006 | K060094 | ARCADIA MEDICAL SILICONE WIRE REINFORCED ENDOTRACHEAL TUBES Arcadia Medical Corporation | BTR |
| Dec 13, 2005 | K052233 | TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM Etview , Ltd., IL | BTR |
| Dec 13, 2005 | K051993 | LMA FASTRACH ETT SINGLE USE The Laryngeal Mask Co., Ltd. | BTR |
| Jul 15, 2005 | K050785 | AMSINO ENDOTRACHEAL TUBE Amsino International, Inc. | BTR |
| Jun 30, 2005 | K050803 | PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBES Vitaid, Ltd. | BTR |
| Mar 18, 2005 | K041311 | TIGER ENDOTRACHEAL TUBES (VARIOUS MODELS AND SIZES) Tiger Medical Products, Ltd. | BTR |
| Feb 18, 2005 | K042683 | WELL LEAD ENDOTRACHEAL TUBE Well Lead Medical Instruments | BTR |
| Jan 7, 2005 | K043205 | RUSCH EASY TUBE Teleflex Medical | BTR |
| Jan 7, 2005 | K041917 | PLASIATEK ACTUATOR Plasiatek, LLC | BTR |
| Jun 10, 2004 | K040657 | BOUSSIGNAC/VYGON ENDOTRACHEAL TUBE, MODEL 6501.25/30/35 AND 6502.70/75/80 Vygon SA | BTR |
| Mar 12, 2004 | K031794 | ENDOFLEX TRACHEAL TUBE Merlyn Associates, Inc. | BTR |
| Jan 26, 2004 | K032112 | P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED) Portex , Ltd., GB | BTR |
| Nov 14, 2003 | K030792 | BARD ENDOTRACHEAL TUBE, CUFFED C.R. Bard, Inc. | BTR |
| Dec 23, 2002 | K023964 | RUSCH MICROLARYNGEAL TUBE Rusch Intl. | BTR |
| Sep 11, 2002 | K021044 | MADETT Wolfe Tory Medical, Inc. | BTR |
| Aug 1, 2002 | K021540 | RUSCH EDGAR TUBE Rusch Intl. | BTR |
| Jun 4, 2002 | K013321 | SILICONE TRACHEAL T-TUBES Technical Products, Inc. | BTR |
| Mar 15, 2000 | K000045 | POSITUBE Paraproducts, Inc. | BTR |
| Feb 4, 2000 | K991580 | ILM ENDOTRACHEAL TUBE The Laryngeal Mask Co., Ltd. | BTR |
| Feb 2, 2000 | K993786 | RUSCH ORAL/NASAL (SAFETY CLEAR PLUS) TRACHEAL TUBE CUFFED, MAGILL/MURPHY Rusch Intl. | BTR |
| Jan 20, 2000 | K993582 | MODIFICATION TO LASER-SHIELD II Xomed, Inc. | BTR |
| Aug 3, 1999 | K990619 | RUSCH REINFORCED ENDOTRACHEAL (OR TRACHEAL) TUBE- CUFFED AND UNCUFFED MURPHY/MAGILL, STERILE Rusch Intl. | BTR |
| Jul 15, 1999 | K984528 | PARKER FLEX-TIP TRACHEAL TUBE Parker Medical Assoc. | BTR |
| Mar 26, 1999 | K990556 | ESOPHAGEAL INTUBATION DETECTOR Wolfe Tory Medical, Inc. | BTR |
| Feb 11, 1999 | K990098 | VENTLAB VERIFY II Ventlab Corp. | BTR |
| Jul 17, 1998 | K981891 | AMBU TUBECHECK Ambu, Inc. | BTR |
| Mar 2, 1998 | K971759 | MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTER Green Field Medical Sourcing, Inc. | BTR |
| Feb 13, 1998 | K973191 | THE VISUALIZED ENDOTRACHEAL TUBE SYSTEM OR VETT SYSTEM Pulmonx | BTR |
| Aug 21, 1997 | K970196 | T-WALL UNCUFFED TRACHEAL TUBE Vital Signs, Inc. | BTR |
| Mar 20, 1997 | K965132 | HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES Mallinckrodt Medical | BTR |
| Nov 21, 1996 | K962389 | EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE Unomedical Sdn Bhd | BTR |
| Oct 8, 1996 | K962098 | ESOPHAGEAL INTUBATION DETECTOR Kirk Specialty Systems | BTR |
| Aug 16, 1996 | K961837 | RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY Rusch Intl. | BTR |
| Jun 27, 1996 | K961840 | RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHY Rusch Intl. | BTR |
| Jun 27, 1996 | K955495 | RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE Rusch, Inc. | BTR |
| May 22, 1996 | K960795 | VYGON DOUBLE LUMEN ENDOTRACHEAL TUBE Vygon Corp. | BTR |
| May 10, 1996 | K954585 | RUSCH PEDIATRIC REINFORCED TRAHEAL (OR ENDOTRACHEAL) TUBE - UNCUFFED, STERILE Rusch Intl. | BTR |
| Apr 19, 1996 | K960450 | HEBELER SAFE-T-TUBE Boston Medical Products, Inc. | BTR |
| Dec 15, 1995 | K951768 | TEVES ECM PLUS THERMOCOUPLE Advanced Medical Concepts, Inc. | BTR |
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