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FDA 510(k)

HEMOCATH REPAIR KIT

K-Number: K840424 · 1984-03-05

ApplicantQuinton, Inc.
Decision Date1984-03-05
Product CodeKNZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HEMOCATH REPAIR KIT is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1984-03-05 under 510(k) number K840424. 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 HEMOCATH REPAIR KIT?

HEMOCATH REPAIR KIT is a medical device that received FDA 510(k) clearance on 1984-03-05. The listed applicant is Quinton, Inc.. The 510(k) number is K840424.

When did HEMOCATH REPAIR KIT receive FDA 510(k) clearance?

HEMOCATH REPAIR KIT received FDA 510(k) clearance on 1984-03-05, under 510(k) number K840424.

Who is the listed applicant for HEMOCATH REPAIR KIT?

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

What is the FDA product code for HEMOCATH REPAIR KIT?

The FDA product code for HEMOCATH REPAIR KIT is KNZ.

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Other records listing Quinton, 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.

K032038PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601K021906QUINTON Q-CATH, MODEL 000460K003576Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503K001492QUINTON Q-STRESS, MODEL 000483K992908Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)K990866QUINTON MEDTRACK CR PLUS TREADMILL

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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.K842416DUO FLOW CATHETER-MC 54Medical Components, Inc.K841530DOUBLE LUMEN SUBLCAVIAN-FEMORALMedical Components, Inc.K841119TOPS DISPOS. INFUSION SET/HEMODIALYSISTop Surgical Manufacturers Co.

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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