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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 a medical device manufactured by Pristine Access Technologies , Ltd.. It received FDA 510(k) clearance on 2019-05-31 under approval 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. It is manufactured by Pristine Access Technologies , Ltd.. The 510(k) number is K182443.

When was Pristine Hemodialysis Catheter approved by the FDA?

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

What company makes Pristine Hemodialysis Catheter?

Pristine Hemodialysis Catheter is manufactured by Pristine Access Technologies , Ltd..

What is the FDA product code for Pristine Hemodialysis Catheter?

The FDA product code for Pristine Hemodialysis Catheter is MSD.

Related Clinical Trials

NCT07019610 Chlorhexidine Caps for CLABSI Prevention in Hemodialysis: a Pilot Randomized Controlled Trial NOT_YET_RECRUITING

Related Devices (Code: MSD)

K161026NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm)Marvao Medical Devices, Ltd. K151967Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis CatheterMerit Medical Systems, Inc. K171571NexSite HD, Hemodialysis Step Tip Catheter (60cm)Marvao Medical Devices, Ltd. K171618Symetrex Long Term Hemodialysis CatheterMedcomp (Dba Medical Components, Inc.) K17366715.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with SideholesMedical Components, Inc. (dba MedComp) K173805NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm)Marvao Medical Devices, Ltd.

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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