510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K897046Substantially Equivalent

Laser Resistant Tracheal Tube

Sheridan Catheter Corp., Argyle NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K897046 is the FDA 510(k) clearance record for LASER RESISTANT TRACHEAL TUBE, a class II device, cleared for Sheridan Catheter Corp. on under FDA product code CBI (Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)). FDA records list 39 510(k) clearances for Sheridan Catheter Corp., from to . As of , FDA records show no recalls naming K897046.

Clearance record

Decision date
Received
(95 days to decision)
Product code
CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Regulation
21 CFR 868.5740
Device class
Class II
Review panel
Anesthesiology
Applicant
Sheridan Catheter Corp. Rte. 40, Argyle NY
Third party review
No

Clearances, product code CBI

Trailing 12 months
2 clearances under product code CBI in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CBI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260