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FDA 510(k)

LASER RESISTANT TRACHEAL TUBE

K-Number: K897046 · 1990-03-23

ApplicantSheridan Catheter Corp.
Decision Date1990-03-23
Product CodeCBI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LASER RESISTANT TRACHEAL TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Sheridan Catheter Corp.. It received FDA 510(k) clearance on 1990-03-23 under 510(k) number K897046. 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 LASER RESISTANT TRACHEAL TUBE?

LASER RESISTANT TRACHEAL TUBE is a medical device that received FDA 510(k) clearance on 1990-03-23. The listed applicant is Sheridan Catheter Corp.. The 510(k) number is K897046.

When did LASER RESISTANT TRACHEAL TUBE receive FDA 510(k) clearance?

LASER RESISTANT TRACHEAL TUBE received FDA 510(k) clearance on 1990-03-23, under 510(k) number K897046.

Who is the listed applicant for LASER RESISTANT TRACHEAL TUBE?

The FDA 510(k) record lists Sheridan Catheter Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LASER RESISTANT TRACHEAL TUBE?

The FDA product code for LASER RESISTANT TRACHEAL TUBE is CBI.

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Other records listing Sheridan Catheter Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K922894LAZER-TRACH TRACHEAL TUBEK890823ACCESSORY TO CLINICAL ELECTRONIC THERMOMETERK884765CLINICAL ELECTRONIC THERMOMETERSK882918KIM NASO-INTESTINAL TUBEK882127CLINICAL ELECTRONIC THERMOMETERSK881368CLINICAL ELECTONIC THERMOMETERS

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Related Devices (Code: CBI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251950Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S)Hangzhou Tappa Medical Technology Co., Ltd.K253096Chartis Precision CatheterPulmonx CorporationK232529Disposable Double Lumen Endobronchial TubeShenzhen Insighters Medical Technology Co., Ltd.K232580Disposable Endobronchial Blocker TubeShenzhen Insighters Medical Technology Co., Ltd.K222340Chartis Precision CatheterPulmonx CorporationK201026sOLVe TubeHytek Medical, 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.

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