510(k) clearances

Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)

Covidien, LLC · Anesthesiology

K233341Substantially EquivalentTraditionalBTR
Open FDA's page for this record
Third party flag
N
City
Boulder
Advisory committee description
Anesthesiology
Address 1
6135 Gunbarrel Ave.
Statement or summary
Summary
Product code
BTR
Zip code
80301
Applicant
Covidien, LLC
Decision date
2024-05-20
Decision code
SESE
Country code
US
Advisory committee
AN
Contact
Stephanie Reneau
K number
K233341
State
CO
Date received
2023-09-29
Review advisory committee
AN
Postal code
80301
Decision description
Substantially Equivalent
Clearance type
Traditional
Device name

Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)

Harmonized identifiers (openFDA)
Device name
Tube, Tracheal (W/Wo Connector)
Medical specialty description
Anesthesiology
Regulation number
868.5730
Device class
2
Registration number
1526611, 3018094310, 3004056932, 3014479313, 1930870, 3009118476, 8041005, 3015058854, 3005382983, 3003674698, 8040412, 3004527595, 9616567, 1314417, 3005160810, 3021632375, 3005609751, 8021995, 3030412764, 3009050824, 3008439484, 3004111573, 3043226252, 2030598, 3011137372, 3041679947, 3006157842, 3006017180, 1420054, 8020889, 3043543260, 3011237770, 9612501, 3003903031, 3010131137, 2025816, 3027977504, 3010594263, 1220850, 3030733800 +96 more
FEI number
1526611, 3018094310, 3004056932, 3014479313, 1930870, 3009118476, 3015058854, 3005382983, 3002808507, 3003674698, 2523865, 3004527595, 1314417, 3005160810, 3021632375, 3005609751, 3030412764, 3009050824, 3008439484, 3004111573, 3043226252, 3041679947, 3006157842, 3006017180, 1420054, 1000138054, 3003076831, 3043543260, 3011237770, 3003903031, 3010131137, 2025816, 3027977504, 3002807626, 3010594263, 1000511237, 1220850, 3003382061, 1000113735, 3030733800 +96 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.