510(k) K834565
K834565 is an FDA 510(k) premarket notification submitted by Portex, Inc. for the device "ENDOBRONCHIAL TWIN LUMEN TUBE". The FDA issued a decision of Substantially Equivalent on January 17, 1984. The device falls under product code BTS (Tube, Bronchial (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5720. Portex, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 1984
- Date Received
- December 28, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Bronchial (W/Wo Connector)
- Device Class
- Class II
- Regulation Number
- 868.5720
- Review Panel
- AN
- Submission Type