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FDA 510(k)

Pristine Hemodialysis Catheter

K-Number: K182443 · 2019-05-31

ApplicantPristine Access Technologies , Ltd.
Decision Date2019-05-31
Product CodeMSD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Pristine Hemodialysis Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Pristine Access Technologies , Ltd.. It received FDA 510(k) clearance on 2019-05-31 under 510(k) number K182443. 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 Pristine Hemodialysis Catheter?

Pristine Hemodialysis Catheter is a medical device that received FDA 510(k) clearance on 2019-05-31. The listed applicant is Pristine Access Technologies , Ltd.. The 510(k) number is K182443.

When did Pristine Hemodialysis Catheter receive FDA 510(k) clearance?

Pristine Hemodialysis Catheter received FDA 510(k) clearance on 2019-05-31, under 510(k) number K182443.

Who is the listed applicant for Pristine Hemodialysis Catheter?

The FDA 510(k) record lists Pristine Access Technologies , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pristine Hemodialysis Catheter?

The FDA product code for Pristine Hemodialysis Catheter is MSD.

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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