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FDA 510(k)

MEDCOMP ASH SPLIT-CATH 28CM, MEDCOMP ASH SPLIT-CATH 32CM

K-Number: K972207 · 1998-02-23

ApplicantMedcomp
Decision Date1998-02-23
Product CodeMSD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MEDCOMP ASH SPLIT-CATH 28CM, MEDCOMP ASH SPLIT-CATH 32CM is the device name listed in this FDA 510(k) record. The listed applicant is Medcomp. It received FDA 510(k) clearance on 1998-02-23 under 510(k) number K972207. 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 ASH SPLIT-CATH 28CM, MEDCOMP ASH SPLIT-CATH 32CM?

MEDCOMP ASH SPLIT-CATH 28CM, MEDCOMP ASH SPLIT-CATH 32CM is a medical device that received FDA 510(k) clearance on 1998-02-23. The listed applicant is Medcomp. The 510(k) number is K972207.

When did MEDCOMP ASH SPLIT-CATH 28CM, MEDCOMP ASH SPLIT-CATH 32CM receive FDA 510(k) clearance?

MEDCOMP ASH SPLIT-CATH 28CM, MEDCOMP ASH SPLIT-CATH 32CM received FDA 510(k) clearance on 1998-02-23, under 510(k) number K972207.

Who is the listed applicant for MEDCOMP ASH SPLIT-CATH 28CM, MEDCOMP ASH SPLIT-CATH 32CM?

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 MEDCOMP ASH SPLIT-CATH 28CM, MEDCOMP ASH SPLIT-CATH 32CM?

The FDA product code for MEDCOMP ASH SPLIT-CATH 28CM, MEDCOMP ASH SPLIT-CATH 32CM 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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