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FDA 510(k)

ORAL-CATH SUCTION CATHETER

K-Number: K903552 · 1991-01-02

ApplicantConcord Protex
Decision Date1991-01-02
Product CodeBSY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ORAL-CATH SUCTION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Concord Protex. It received FDA 510(k) clearance on 1991-01-02 under 510(k) number K903552. 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 ORAL-CATH SUCTION CATHETER?

ORAL-CATH SUCTION CATHETER is a medical device that received FDA 510(k) clearance on 1991-01-02. The listed applicant is Concord Protex. The 510(k) number is K903552.

When did ORAL-CATH SUCTION CATHETER receive FDA 510(k) clearance?

ORAL-CATH SUCTION CATHETER received FDA 510(k) clearance on 1991-01-02, under 510(k) number K903552.

Who is the listed applicant for ORAL-CATH SUCTION CATHETER?

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

What is the FDA product code for ORAL-CATH SUCTION CATHETER?

The FDA product code for ORAL-CATH SUCTION CATHETER 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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