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FDA 510(k)

MGN SUCTION CATHETER

K-Number: K811542 · 1981-06-18

ApplicantMgn Medical Manufacturing, Inc.
Decision Date1981-06-18
Product CodeBSY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MGN SUCTION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Mgn Medical Manufacturing, Inc.. It received FDA 510(k) clearance on 1981-06-18 under 510(k) number K811542. 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 MGN SUCTION CATHETER?

MGN SUCTION CATHETER is a medical device that received FDA 510(k) clearance on 1981-06-18. The listed applicant is Mgn Medical Manufacturing, Inc.. The 510(k) number is K811542.

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

MGN SUCTION CATHETER received FDA 510(k) clearance on 1981-06-18, under 510(k) number K811542.

Who is the listed applicant for MGN SUCTION CATHETER?

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

What is the FDA product code for MGN SUCTION CATHETER?

The FDA product code for MGN SUCTION CATHETER is BSY.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Mgn Medical Manufacturing, 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.

K821703MGN CONDUCTIVE CONNECTING TUBE, STERILEK811533MGN FEEDING TUBEK811541MGN CONNECTING TUBE

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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