BTS — Tube, Bronchial (W/Wo Connector) Class II
FDA product code BTS covers "Tube, Bronchial (W/Wo Connector)", a Class II medical device regulated under 21 CFR 868.5720. Submissions are reviewed by the Anesthesiology panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- BTS
- Device Class
- Class II
- Regulation Number
- 868.5720
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K953963 | rusch | RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIA | November 27, 1995 |
| K951091 | rusch intl | RUSCH ENDOBRONCHIAL TUBE SETS | June 8, 1995 |
| K902116 | concord/portex | MODIFIED ENDOBRONCHIAL TUBE | August 3, 1990 |
| K834565 | portex | ENDOBRONCHIAL TWIN LUMEN TUBE | January 17, 1984 |
| K833297 | surgitek | BRONCHOSCOPY TUBE W/ULTRA LOCUFF | December 27, 1983 |
| K771219 | mallinckrodt critical care | BRONCHO-CATH | August 4, 1977 |