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FDA 510(k)

TRACH-EZE

K-Number: K903740 · 1990-12-06

ApplicantSorex Medical
Decision Date1990-12-06
Product CodeBSY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRACH-EZE is the device name listed in this FDA 510(k) record. The listed applicant is Sorex Medical. It received FDA 510(k) clearance on 1990-12-06 under 510(k) number K903740. The device is classified under product code BSY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACH-EZE?

TRACH-EZE is a medical device that received FDA 510(k) clearance on 1990-12-06. The listed applicant is Sorex Medical. The 510(k) number is K903740.

When did TRACH-EZE receive FDA 510(k) clearance?

TRACH-EZE received FDA 510(k) clearance on 1990-12-06, under 510(k) number K903740.

Who is the listed applicant for TRACH-EZE?

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

What is the FDA product code for TRACH-EZE?

The FDA product code for TRACH-EZE is BSY.

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Other records listing Sorex Medical 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.

K923843FOGLESSK913036PLUME MASTERK911070PICC-FIXK911150SOREX SAFE-AIRK910315PICC INSERTION KIT/P.I.C. & PICC EXCHANG KIT/P.E.KK905572EDLICH WOUND MANAGEMENT TRAY

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Related Devices (Code: BSY)

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.

K031997MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEMMallinckrodt Dar S.R.L.K992902AMBU HAND POWER SUCTION PUMPAmbu, Inc.K982945DUAL PURPOSE CLOSED CATHETERSpirit Medical Systems, Inc.K981910SUCTION CATHETERNi-Med, Inc.K972258HI-CARE CLOSED SUCTION SYSTEMMallinckrodt MedicalK973199AMSINO SUCTION CATHETERAmsino Intl., 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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