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 |
|---|---|---|---|
| Feb 3, 1992 | K915799 | BIVONA SLEEP APNEA TUBE Bivona Medical Technologies | BTR |
| Aug 26, 1991 | K912290 | HEALY/MONTGOMERY STENT SYSTEM (HMS SYSTEM(TM)) Boston Medical Products, Inc. | BTR |
| Mar 15, 1991 | K902193 | KEVTEK LASER-STOP ENDOTRACHEAL TUBE LASER-STOP Kevtek Medical Products, Inc. | BTR |
| Feb 4, 1991 | K903876 | MONTGOMERY(R) TAPERED SAFE-T-TUBE(TM) Boston Medical Products, Inc. | BTR |
| Apr 16, 1990 | K900457 | CUFFED LINDER NASOTRACHEAL AIRWAY Polamedco, Inc. | BTR |
| Jan 9, 1990 | K896181 | APT TRACHEA TUBES Advanced Pulmonary Technologies, Inc. | BTR |
| Oct 30, 1989 | K893609 | TEVES ECM (ENDOTRACHEAL CARDIAC MONITOR) Leonides Y. Teves, M.D., P.A. | BTR |
| Oct 13, 1989 | K895132 | CONNELL-STEPHENS ENDO ANESS TUBE The Traumafuse Co. | BTR |
| Oct 13, 1989 | K894669 | LASER SHIELDING TUBE Vitaid, Ltd., CA | BTR |
| Jun 12, 1989 | K892432 | KENDALL CURITY ENDOTRACHEAL TUBES The Kendal Co. | BTR |
| Sep 8, 1988 | K883096 | TRACHEAL TUBE LASER SHIELD KIT Americal Corp. | BTR |
| May 31, 1988 | K881496 | LINDER NASOTRACHEAL AIRWAY Polamedco, Inc. | BTR |
| May 19, 1988 | K881313 | IQK-200 Medical Repackers Co. | BTR |
| May 6, 1988 | K880487 | NEOTECH MECONIUM ASPIRATOR (STERILE) Neotech Products, Inc. | BTR |
| Apr 29, 1988 | K880960 | NDYAG LASER TRACHEAL TUBE Sheridan Catheter Corp. | BTR |
| Apr 11, 1988 | K874679 | TRACHEAL TUBE LASER SHIELD KIT Americal Corp. | BTR |
| Nov 6, 1987 | K873461 | LASER-FLEX(TM) TRACHEAL TUBE (CUFFED) Mallinckrodt Critical Care | BTR |
| Sep 16, 1987 | K871632 | NASOGASTRIC VOICETUBE American Omni Medical, Inc. | BTR |
| Aug 17, 1987 | K872366 | AIRE-CUF POLYESTER RE-ENFORCED ENDOTRACHEAL TUBE Bivona Medical Technologies | BTR |
| Aug 10, 1987 | K872616 | BELL/MCKAY TRACHEAL TUBE Sheridan Catheter Corp. | BTR |
| Jun 15, 1987 | K871263 | MULTIPLE PHARMA-PLAST TRACHEAL TUBE Pharma-Plast USA, Inc., CA | BTR |
| May 8, 1987 | K870470 | TRACH MATE TRACHEAL TUBE Mccormick Laboratories, Inc. | BTR |
| May 8, 1987 | K870387 | EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE American Pharmaseal Div. Ahsc | BTR |
| Apr 21, 1987 | K871204 | CUFFED TRACHEAL TUBE (MULTIPLE) Mallinckrodt Critical Care | BTR |
| Mar 9, 1987 | K864533 | HOOD BIFURCATED T-TUBE Hood Laboratories | BTR |
| Nov 10, 1986 | K864161 | TOOB-CHEQ CARBON DIOXIDE GAS ANALYZER Toob-Cheq, Inc. | BTR |
| Oct 30, 1986 | K862950 | WHITE-SIPOSS TUBE, CAT NO WS-1 American Omni Medical, Inc. | BTR |
| Oct 15, 1986 | K862238 | BIVONA FOME-CUF LASER ENDOTRACHEAL TUBE Bivona Medical Technologies | BTR |
| Aug 1, 1986 | K862666 | UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE) Mallinckrodt Critical Care | BTR |
| Jul 11, 1986 | K862347 | ENDOTRACHEAL TUBE, ACCESSORY Sheridan Catheter Corp. | BTR |
| Jun 5, 1986 | K860901 | LASER RESISTANT TRACHEAL TUBE (TENTATIVE) Mallinckrodt Critical Care | BTR |
| May 6, 1986 | K861463 | SHILEY SLEEP APNEA LOW PRESSURE CUFFED TRACH TUBE Shiley, Inc. | BTR |
| May 6, 1986 | K861462 | SHILEY SLEEP APNEA CUFFLESS TRACHEOSTOMY TUBE Shiley, Inc. | BTR |
| May 6, 1986 | K861461 | SHILEY SLEEP APNEA CUFFLESS FENESTRATED TRACH TUBE Shiley, Inc. | BTR |
| May 6, 1986 | K861454 | END TIDAL CO2 TUBE Sheridan Catheter Corp. | BTR |
| Mar 4, 1986 | K860105 | SPIRAL-FLEX Sheridan Catheter Corp. | BTR |
| Jan 3, 1986 | K854632 | ENDOTRACHEAL TUBE GUIDE OR INTUBATION STYLETTE Respiratory Support Products, Inc. | BTR |
| Oct 1, 1985 | K853502 | VARIOUS FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY Bivona Medical Technologies | BTR |
| Aug 13, 1985 | K852025 | BRANDT TRACHEAL TUBE(TENTATIVE) Mallinckrodt Critical Care | BTR |
| Jul 8, 1985 | K852493 | UNCUFFED HI-LO JET TRACHEAL TUBE Mallinckrodt Critical Care | BTR |
| Mar 4, 1985 | K844696 | TROGIDE Carmel Medical Devices | BTR |
| Feb 21, 1985 | K843988 | S.E.T. TUBE Bfw Laboratories, Inc. | BTR |
| Feb 12, 1985 | K844564 | ARGYLE LASER RESISTANT TRACHEAL TUBE W/MURPHY EYE Sherwood Medical Co. | BTR |
| Jan 14, 1985 | K844746 | TRACHEAL TUBE W/AIRWAY INTUBATOR Sheridan Catheter Corp. | BTR |
| Dec 14, 1984 | K843936 | MONTGOMERY SAFE-T-TUBE Boston Medical Products, Inc. | BTR |
| Dec 4, 1984 | K844296 | TRACHEAL TUBE, REINFORCED, CUFFED Sheridan Catheter Corp. | BTR |
| Oct 19, 1984 | K843714 | DOUBLE CONTOURED CUFF TRACHEAL TUBE Ohmeda Medical | BTR |
| Jul 26, 1984 | K841872 | UNCUFFED REINFORCED TRACHEAL TUBE Mallinckrodt Critical Care | BTR |
| Jul 25, 1984 | K842635 | SHERIDAN/ENDO-PAK Sheridan Catheter Corp. | BTR |
| Jul 11, 1984 | K842558 | SHERIDAN/INTENSA TUBE Sheridan Catheter Corp. | BTR |
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