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FDA 510(k)

TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM

K-Number: K961707 · 1997-03-11

ApplicantSorenson Critical Care
Decision Date1997-03-11
Product CodeBSY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sorenson Critical Care. It received FDA 510(k) clearance on 1997-03-11 under 510(k) number K961707. 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 CLOSED VENTILATION SUCTION SYSTEM?

TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM is a medical device that received FDA 510(k) clearance on 1997-03-11. The listed applicant is Sorenson Critical Care. The 510(k) number is K961707.

When did TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM receive FDA 510(k) clearance?

TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM received FDA 510(k) clearance on 1997-03-11, under 510(k) number K961707.

Who is the listed applicant for TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM?

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

What is the FDA product code for TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM?

The FDA product code for TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM is BSY.

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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

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

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