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FDA 510(k)

14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55

K-Number: K030502 · 2003-05-20

ApplicantMedcomp
Decision Date2003-05-20
Product CodeMSD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55 is the device name listed in this FDA 510(k) record. The listed applicant is Medcomp. It received FDA 510(k) clearance on 2003-05-20 under 510(k) number K030502. 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 14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55?

14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55 is a medical device that received FDA 510(k) clearance on 2003-05-20. The listed applicant is Medcomp. The 510(k) number is K030502.

When did 14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55 receive FDA 510(k) clearance?

14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55 received FDA 510(k) clearance on 2003-05-20, under 510(k) number K030502.

Who is the listed applicant for 14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55?

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

What is the FDA product code for 14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55?

The FDA product code for 14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55 is MSD.

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Other records listing Medcomp as applicant

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Related Devices (Code: MSD)

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.

K241581Hemodialysis CatheterHaolang Medical USA CorporationK210461End CapMedical Components Inc (Medcomp)K203575GlidePath Retro Long-Term Hemodialysis CatheterC.R. Bard, Inc.K211410GlidePath 13F Long-Term Hemodialysis CatheterBard Peripheral Vascular, Inc.K203767Pristine Long-Term Hemodialysis CatheterC B Bard, Inc.K202150GlidePath 7.5F Long-Term Dialysis CatheterC.R. Bard, 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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