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FDA 510(k)

INTEGRAL HEMODIALYSIS CATHETER

K-Number: K040260 · 2004-03-05

ApplicantArrow Int'L.
Decision Date2004-03-05
Product CodeMSD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INTEGRAL HEMODIALYSIS CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Arrow Int'L.. It received FDA 510(k) clearance on 2004-03-05 under 510(k) number K040260. 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 INTEGRAL HEMODIALYSIS CATHETER?

INTEGRAL HEMODIALYSIS CATHETER is a medical device that received FDA 510(k) clearance on 2004-03-05. The listed applicant is Arrow Int'L.. The 510(k) number is K040260.

When did INTEGRAL HEMODIALYSIS CATHETER receive FDA 510(k) clearance?

INTEGRAL HEMODIALYSIS CATHETER received FDA 510(k) clearance on 2004-03-05, under 510(k) number K040260.

Who is the listed applicant for INTEGRAL HEMODIALYSIS CATHETER?

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

What is the FDA product code for INTEGRAL HEMODIALYSIS CATHETER?

The FDA product code for INTEGRAL HEMODIALYSIS CATHETER is MSD.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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