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FDA 510(k)

DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER

K-Number: K042016 · 2004-09-23

ApplicantDatascope Corp.
Decision Date2004-09-23
Product CodeMSD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp.. It received FDA 510(k) clearance on 2004-09-23 under 510(k) number K042016. 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 DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER?

DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER is a medical device that received FDA 510(k) clearance on 2004-09-23. The listed applicant is Datascope Corp.. The 510(k) number is K042016.

When did DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER receive FDA 510(k) clearance?

DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER received FDA 510(k) clearance on 2004-09-23, under 510(k) number K042016.

Who is the listed applicant for DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER?

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

What is the FDA product code for DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER?

The FDA product code for DATASCOPE PROGUIDE CHRONIC DIALYSIS 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

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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