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)

Sheridan Endobronchial Tubes

K-Number: K180253 · 2018-11-02

ApplicantTeleflex Medical
Decision Date2018-11-02
Product CodeCBI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Sheridan Endobronchial Tubes is a medical device manufactured by Teleflex Medical. It received FDA 510(k) clearance on 2018-11-02 under approval number K180253. The device is classified under product code CBI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sheridan Endobronchial Tubes?

Sheridan Endobronchial Tubes is a medical device that received FDA 510(k) clearance on 2018-11-02. It is manufactured by Teleflex Medical. The 510(k) number is K180253.

When was Sheridan Endobronchial Tubes approved by the FDA?

Sheridan Endobronchial Tubes received FDA 510(k) clearance on 2018-11-02, under approval number K180253.

What company makes Sheridan Endobronchial Tubes?

Sheridan Endobronchial Tubes is manufactured by Teleflex Medical.

What is the FDA product code for Sheridan Endobronchial Tubes?

The FDA product code for Sheridan Endobronchial Tubes is CBI.

Other Devices by Teleflex Medical

K161758Weck Auto Endo10 Automatic Endoscopic Clip Applier K153470MADgic Laryngo-Tracheal Mucosal Atomization Device K173321StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1”) Peripheral Nerve Block Needle K180588FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous Device K173596Rusch Intermittent Urethral Catheters K190026Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)

View all 20 devices →

Related Devices (Code: CBI)

K1605425.0 Fr Arndt Endobronchial Blocker SetCook Incorporated K152251Endobronchial TubeHenan Tuoren Medical Device Co., Ltd. K181886VivaSight-DL SystemEtview , Ltd. K200968ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39RInsung Medical Co., Ltd. K201026sOLVe TubeHytek Medical, Inc. K203749Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter CableAmbu A/S

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.

↑