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FDA 510(k)

TRACHEOBRONCHIAL SUCTION CATHETER

K-Number: K813209 · 1981-12-09

ApplicantHydromer, Inc.
Decision Date1981-12-09
Product CodeBSY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRACHEOBRONCHIAL SUCTION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Hydromer, Inc.. It received FDA 510(k) clearance on 1981-12-09 under 510(k) number K813209. 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 TRACHEOBRONCHIAL SUCTION CATHETER?

TRACHEOBRONCHIAL SUCTION CATHETER is a medical device that received FDA 510(k) clearance on 1981-12-09. The listed applicant is Hydromer, Inc.. The 510(k) number is K813209.

When did TRACHEOBRONCHIAL SUCTION CATHETER receive FDA 510(k) clearance?

TRACHEOBRONCHIAL SUCTION CATHETER received FDA 510(k) clearance on 1981-12-09, under 510(k) number K813209.

Who is the listed applicant for TRACHEOBRONCHIAL SUCTION CATHETER?

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

What is the FDA product code for TRACHEOBRONCHIAL SUCTION CATHETER?

The FDA product code for TRACHEOBRONCHIAL 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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