Tube, Bronchial (W/Wo Connector)
The Tube, Bronchial (W/Wo Connector) is a tube designed for endobronchial intubation to isolate one lung from the other during thoracic surgery, allowing selective ventilation or collapse of individual lung sections. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BTS, regulated under 21 CFR 868.5720 in the Anesthesiology specialty. This device is designated as life-sustaining or life-supporting.
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Basic Information
- Product Code
- BTS
- Device Class
- FDA class 2
- Regulation Number
- 868.5720
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K953963 | RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION | Nov 27, 1995 | Substantially Equivalent | Rusch, Inc. |
| K951091 | RUSCH ENDOBRONCHIAL TUBE SETS | Jun 08, 1995 | Substantially Equivalent | Rusch Intl. |
| K902116 | MODIFIED ENDOBRONCHIAL TUBE | Aug 03, 1990 | Substantially Equivalent | Concord/Portex |
| K834565 | ENDOBRONCHIAL TWIN LUMEN TUBE | Jan 17, 1984 | Substantially Equivalent | Portex, Inc. |
| K833297 | BRONCHOSCOPY TUBE W/ULTRA LOCUFF | Dec 27, 1983 | Substantially Equivalent | Surgitek |
| K771219 | BRONCHO-CATH | Aug 04, 1977 | Substantially Equivalent | Mallinckrodt Critical Care |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.