Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K233341 · 2024-05-20

ApplicantCovidien, LLC
Decision Date2024-05-20
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410) is a medical device manufactured by Covidien, LLC. It received FDA 510(k) clearance on 2024-05-20 under approval number K233341. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410) is a medical device that received FDA 510(k) clearance on 2024-05-20. It is manufactured by Covidien, LLC. The 510(k) number is K233341.

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

Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410) received FDA 510(k) clearance on 2024-05-20, under approval number K233341.

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

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

What is the FDA product code for Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)?

The FDA product code for Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410) is BTR.

Other Devices by Covidien, LLC

K163105Emprint Ablation System K163098Tri-Staple 2.0 Intelligent Cartridge K160290Valleylab REM Polyhesive Infant Patient Return Electrode K160654GastriSail Gastric Positioning System 40 Fr/CH (13.3mm) K152794Cytosponge Cell Collection Device K160360Barrx FLEX RFA Energy Generator

View all 57 devices →

Related Devices (Code: BTR)

K152438ETView VivaSight-SL (TVT) systemEtview , Ltd. K161813Frova Intubating IntroducerWilliam Cook Europe Aps K160694Disposable Endotracheal tube, sterile, AccuCuffTianjin Medis Medical Device Co., Ltd. K181880VivaSight-SL (TVT) systemEtview , Ltd. K171917Frova Intubating IntroducerCook Incorporated K172208NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded StyletNevap, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑