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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 9, 1984 | K840539 | DISPOS. LOW PRESS. CUFFED TRACHEOSTOMY Shiley, Inc. | BTO |
| Jan 27, 1984 | K834179 | H.R. JAKOBI SURG. INSTRUMENTS #9 48 Imm Enterprises , Ltd. | BTO |
| Oct 14, 1983 | K832498 | PERCUTANEOUS TRACHEOSTOMY DEVICE Frederic J. Toye, M.D. | BTO |
| Jul 7, 1983 | K831720 | ARGYLE SILICONE TRACHESTOMY TUBE W/LOW Sherwood Medical Co. | BTO |
| Jul 7, 1983 | K831511 | TRACHEOSTOMY TUBE Implant Technology, Inc. | BTO |
| Mar 29, 1983 | K830509 | EMERGENCY TRACHEOSTOMY & CRICOTHYROIDO- Frederic J. Toye, M.D. | BTO |
| Jan 8, 1983 | K823291 | COMMUNITRACH TUBE Implant Technology, Inc. | BTO |
| Oct 27, 1982 | K822811 | CONTAINERS OF STERILE WATER OS SALINE American Pharmaseal Div. Ahsc | BTO |
| Aug 20, 1982 | K822295 | SURGI TEK'S DISPOS. INNER CANNULA FOR Medical Engineering Corp. | BTO |
| Feb 23, 1982 | K820099 | TRACH TAPE Stan-Pak Ent. | BTO |
| Jun 26, 1981 | K811447 | SHILEY DISPOSABLE CANNULA TRACH. TUBE Shiley, Inc. | BTO |
| May 13, 1981 | K811033 | SHILEY LOW PRESSURE THIN-CUFFED TRACH Shiley, Inc. | BTO |
| May 5, 1981 | K810978 | MONTGOMERY SILICONE TRACHEAL T-TUBE Boston Medical Products, Inc. | BTO |
| Mar 17, 1981 | K810575 | MARTIN TRACH-SECURE Diatek, Inc. | BTO |
| Mar 4, 1981 | K810436 | TRACHEOSTOMA VENT Bivona Medical Technologies | BTO |
| Mar 4, 1981 | K810321 | REINFORCED TRACHEOSTOMY TUBE SET(TENTAT) National Catheter Co. Div. Mallinckrodt | BTO |
| Feb 2, 1981 | K810106 | SHILEY SINGLE CANNULA TRACHEOSTOMY TUBE Shiley, Inc. | BTO |
| Dec 19, 1980 | K802916 | MONTG. TRACHEAL CANNULA Boston Medical Products, Inc. | BTO |
| Sep 9, 1980 | K801379 | CUFFED TRACHEA TUBE FOR USE W/PERTRACH Frederic J. Toye, M.D. | BTO |
| Aug 27, 1980 | K801931 | MARTIN TRACH-SECURE Acucare Medical, Inc. | BTO |
| Oct 30, 1979 | K792069 | TRACHEOSTOMY CARE KIT National Patent Development Corp. | BTO |
| Jun 22, 1979 | K790930 | TRACHE FITTING M-307 Mem Medical, Inc. | BTO |
| Jun 13, 1979 | K791044 | TRACHEOSTOMY TUBES, SHORT AND LONG TERM Extracorporeal Medical Specialities, Inc. | BTO |
| Apr 3, 1979 | K790437 | TRACH CARE KIT Abco Dealers, Inc. | BTO |
| Oct 24, 1978 | K781729 | TRACHEOTOMY TUBES Tracoe Medical GmbH, DE | BTO |
| Dec 20, 1977 | K772138 | ENDOTRACHEAL TUBE Medline Industries, Inc. | BTO |
| Feb 9, 1977 | K770218 | SHILEY PEDIATRIC MURPHY ENDOTRACH. TUBE Shiley, Inc. | BTO |
| Dec 23, 1976 | K761258 | DOVER LOW PRESSURE TRACHEAL TUBE Will Ross Co. | BTO |
| Dec 16, 1976 | K761190 | TRACHEOSTOMY CARE KIT Superior Plastic Products Corp. | BTO |
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