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FDA 510(k)

TRACHAEL SUCTION SET

K-Number: K896887 · 1990-04-23

ApplicantOrion Life Systems, Inc.
Decision Date1990-04-23
Product CodeBSY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRACHAEL SUCTION SET is the device name listed in this FDA 510(k) record. The listed applicant is Orion Life Systems, Inc.. It received FDA 510(k) clearance on 1990-04-23 under 510(k) number K896887. 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 TRACHAEL SUCTION SET?

TRACHAEL SUCTION SET is a medical device that received FDA 510(k) clearance on 1990-04-23. The listed applicant is Orion Life Systems, Inc.. The 510(k) number is K896887.

When did TRACHAEL SUCTION SET receive FDA 510(k) clearance?

TRACHAEL SUCTION SET received FDA 510(k) clearance on 1990-04-23, under 510(k) number K896887.

Who is the listed applicant for TRACHAEL SUCTION SET?

The FDA 510(k) record lists Orion Life Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRACHAEL SUCTION SET?

The FDA product code for TRACHAEL SUCTION SET is BSY.

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Other records listing Orion Life Systems, Inc. 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.

K943835PRE-FILLED SYRINGE W/STERILE .25% ACETC ACIDK943828STERILE WATER FOR IRRIGATIONK943834STERILE .9% SODIUM CHLORIDE SOLUTIONK943831PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATERK943832STERILE .9% SODIUM CHLORIDE FOR IRRATIONK943830PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION

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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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