510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K834565Substantially Equivalent

Endobronchial Twin Lumen Tube

Abbott Medical, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K834565 is the FDA 510(k) clearance record for ENDOBRONCHIAL TWIN LUMEN TUBE, a class II device, cleared for Portex, Inc. on under FDA product code BTS (Tube, Bronchial (W/Wo Connector)). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K834565.

Clearance record

Decision date
Received
(20 days to decision)
Product code
BTS Tube, Bronchial (W/Wo Connector)
Regulation
21 CFR 868.5720
Device class
Class II
Review panel
Anesthesiology
Applicant
Portex, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code BTS

Trailing 12 months

FDA records hold no clearances under product code BTS in the trailing twelve months.

FDA records show no clearances under product code BTS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BTS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260