FDA Product Code
FDA Product Code BTO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Anesthesiology
- 21 CFR Citation
- 868.5800
510(k) Clearances — 129 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K840539 | DISPOS. LOW PRESS. CUFFED TRACHEOSTOMY | Shiley, Inc. | 1984-03-09 | Traditional | PDF ↗ |
| K834179 | H.R. JAKOBI SURG. INSTRUMENTS #9 48 | Imm Enterprises , Ltd. | 1984-01-27 | Traditional | PDF ↗ |
| K832498 | PERCUTANEOUS TRACHEOSTOMY DEVICE | Frederic J. Toye, M.D. | 1983-10-14 | Traditional | PDF ↗ |
| K831511 | TRACHEOSTOMY TUBE | Implant Technology, Inc. | 1983-07-07 | Traditional | PDF ↗ |
| K831720 | ARGYLE SILICONE TRACHESTOMY TUBE W/LOW | Sherwood Medical Co. | 1983-07-07 | Traditional | PDF ↗ |
| K830509 | EMERGENCY TRACHEOSTOMY & CRICOTHYROIDO- | Frederic J. Toye, M.D. | 1983-03-29 | Traditional | PDF ↗ |
| K823291 | COMMUNITRACH TUBE | Implant Technology, Inc. | 1983-01-08 | Traditional | PDF ↗ |
| K822811 | CONTAINERS OF STERILE WATER OS SALINE | American Pharmaseal Div. Ahsc | 1982-10-27 | Traditional | PDF ↗ |
| K822295 | SURGI TEK'S DISPOS. INNER CANNULA FOR | Medical Engineering Corp. | 1982-08-20 | Traditional | PDF ↗ |
| K820099 | TRACH TAPE | Stan-Pak Ent. | 1982-02-23 | Traditional | PDF ↗ |
| K811447 | SHILEY DISPOSABLE CANNULA TRACH. TUBE | Shiley, Inc. | 1981-06-26 | Traditional | PDF ↗ |
| K811033 | SHILEY LOW PRESSURE THIN-CUFFED TRACH | Shiley, Inc. | 1981-05-13 | Traditional | PDF ↗ |
| K810978 | MONTGOMERY SILICONE TRACHEAL T-TUBE | Boston Medical Products, Inc. | 1981-05-05 | Traditional | PDF ↗ |
| K810575 | MARTIN TRACH-SECURE | Diatek, Inc. | 1981-03-17 | Traditional | PDF ↗ |
| K810436 | TRACHEOSTOMA VENT | Bivona Medical Technologies | 1981-03-04 | Traditional | PDF ↗ |
| K810321 | REINFORCED TRACHEOSTOMY TUBE SET(TENTAT) | National Catheter Co. Div. Mallinckrodt | 1981-03-04 | Traditional | PDF ↗ |
| K810106 | SHILEY SINGLE CANNULA TRACHEOSTOMY TUBE | Shiley, Inc. | 1981-02-02 | Traditional | PDF ↗ |
| K802916 | MONTG. TRACHEAL CANNULA | Boston Medical Products, Inc. | 1980-12-19 | Traditional | PDF ↗ |
| K801379 | CUFFED TRACHEA TUBE FOR USE W/PERTRACH | Frederic J. Toye, M.D. | 1980-09-09 | Traditional | PDF ↗ |
| K801931 | MARTIN TRACH-SECURE | Acucare Medical, Inc. | 1980-08-27 | Traditional | PDF ↗ |
| K792069 | TRACHEOSTOMY CARE KIT | National Patent Development Corp. | 1979-10-30 | Traditional | PDF ↗ |
| K790930 | TRACHE FITTING M-307 | Mem Medical, Inc. | 1979-06-22 | Traditional | PDF ↗ |
| K791044 | TRACHEOSTOMY TUBES, SHORT AND LONG TERM | Extracorporeal Medical Specialities, Inc. | 1979-06-13 | Traditional | PDF ↗ |
| K790437 | TRACH CARE KIT | Abco Dealers, Inc. | 1979-04-03 | Traditional | PDF ↗ |
| K781729 | TRACHEOTOMY TUBES | Tracoe Medical GmbH | 1978-10-24 | Traditional | PDF ↗ |
| K772138 | ENDOTRACHEAL TUBE | Medline Industries, Inc. | 1977-12-20 | Traditional | PDF ↗ |
| K770218 | SHILEY PEDIATRIC MURPHY ENDOTRACH. TUBE | Shiley, Inc. | 1977-02-09 | Traditional | PDF ↗ |
| K761258 | DOVER LOW PRESSURE TRACHEAL TUBE | Will Ross Co. | 1976-12-23 | Traditional | PDF ↗ |
| K761190 | TRACHEOSTOMY CARE KIT | Superior Plastic Products Corp. | 1976-12-16 | Traditional | PDF ↗ |
Product code BTO · Class II · Anesthesiology. Data: openFDA.