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FDA 510(k)

Pristine Long-Term Hemodialysis Catheter

K-Number: K203767 · 2021-04-02

ApplicantC B Bard, Inc.
Decision Date2021-04-02
Product CodeMSD
Advisory CommitteeGU
DecisionUnknown

Device Summary

Pristine Long-Term Hemodialysis Catheter is the device name listed in this FDA 510(k) record. The listed applicant is C B Bard, Inc.. It received FDA 510(k) clearance on 2021-04-02 under 510(k) number K203767. The device is classified under product code MSD. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Pristine Long-Term Hemodialysis Catheter?

Pristine Long-Term Hemodialysis Catheter is a medical device that received FDA 510(k) clearance on 2021-04-02. The listed applicant is C B Bard, Inc.. The 510(k) number is K203767.

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

Pristine Long-Term Hemodialysis Catheter received FDA 510(k) clearance on 2021-04-02, under 510(k) number K203767.

Who is the listed applicant for Pristine Long-Term Hemodialysis Catheter?

The FDA 510(k) record lists C B Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pristine Long-Term Hemodialysis Catheter?

The FDA product code for Pristine Long-Term 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.K202150GlidePath 7.5F Long-Term Dialysis CatheterC.R. Bard, Inc.K202176Symetrex LTHD Catheter, Symetrex LTHD Catheter with SideholesMedical Components, Inc. (dba MedComp)

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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