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FDA 510(k)

HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40

K-Number: K994105 · 2001-10-03

ApplicantMedical Components, Inc.
Decision Date2001-10-03
Product CodeMSD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40 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 2001-10-03 under 510(k) number K994105. The device is classified under product code MSD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40?

HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40 is a medical device that received FDA 510(k) clearance on 2001-10-03. The listed applicant is Medical Components, Inc.. The 510(k) number is K994105.

When did HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40 receive FDA 510(k) clearance?

HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40 received FDA 510(k) clearance on 2001-10-03, under 510(k) number K994105.

Who is the listed applicant for HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40?

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 HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40?

The FDA product code for HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40 is MSD.

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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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