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FDA 510(k)

MEDCOMP BIO-FLEX CS CATHETER (CS100)

K-Number: K971925 · 1998-02-23

ApplicantMedical Components, Inc.
Decision Date1998-02-23
Product CodeMSD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MEDCOMP BIO-FLEX CS CATHETER (CS100) 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 1998-02-23 under 510(k) number K971925. 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 MEDCOMP BIO-FLEX CS CATHETER (CS100)?

MEDCOMP BIO-FLEX CS CATHETER (CS100) is a medical device that received FDA 510(k) clearance on 1998-02-23. The listed applicant is Medical Components, Inc.. The 510(k) number is K971925.

When did MEDCOMP BIO-FLEX CS CATHETER (CS100) receive FDA 510(k) clearance?

MEDCOMP BIO-FLEX CS CATHETER (CS100) received FDA 510(k) clearance on 1998-02-23, under 510(k) number K971925.

Who is the listed applicant for MEDCOMP BIO-FLEX CS CATHETER (CS100)?

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 MEDCOMP BIO-FLEX CS CATHETER (CS100)?

The FDA product code for MEDCOMP BIO-FLEX CS CATHETER (CS100) is MSD.

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Related Devices (Code: MSD)

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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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