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FDA 510(k)

DUO FLOW CATHETER-MC 54

K-Number: K842416 · 1984-07-26

ApplicantMedical Components, Inc.
Decision Date1984-07-26
Product CodeKNZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DUO FLOW CATHETER-MC 54 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Components, Inc.. It received FDA 510(k) clearance on 1984-07-26 under 510(k) number K842416. The device is classified under product code KNZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUO FLOW CATHETER-MC 54?

DUO FLOW CATHETER-MC 54 is a medical device that received FDA 510(k) clearance on 1984-07-26. The listed applicant is Medical Components, Inc.. The 510(k) number is K842416.

When did DUO FLOW CATHETER-MC 54 receive FDA 510(k) clearance?

DUO FLOW CATHETER-MC 54 received FDA 510(k) clearance on 1984-07-26, under 510(k) number K842416.

Who is the listed applicant for DUO FLOW CATHETER-MC 54?

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

What is the FDA product code for DUO FLOW CATHETER-MC 54?

The FDA product code for DUO FLOW CATHETER-MC 54 is KNZ.

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Other records listing Medical Components, 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.

K25083614F Duo-Flow® Side X Side Double Lumen CatheterK1316876F X 60CM TRIPLE PRO-LINE CT BASIC IR SETK1306872F & 3F VASCU-SHEATH TEARAWAY INTRODUCERK1309235F DIGNITY CT TITANIUM PORTK124046VALVED TEARAWAY INTRODUCER GENERATION IIK1236173F PRO-PICC

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Related Devices (Code: KNZ)

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.

K842039ARGON DUAL LUMEN HEMODIALYSIS, CATHETERArgon Medical Corp.K844612ACUTE HEMODIALYSIS TRAYSPackaging Technologies, Inc.K842864VACCESS FEMORAL CANNULAVas-Cath of Canada , Ltd.K841530DOUBLE LUMEN SUBLCAVIAN-FEMORALMedical Components, Inc.K841119TOPS DISPOS. INFUSION SET/HEMODIALYSISTop Surgical Manufacturers Co.K840424HEMOCATH REPAIR KITQuinton, 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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