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FDA 510(k)

NexSite HD, Hemodialysis Step Tip Catheter (60cm)

K-Number: K171571 · 2017-11-30

ApplicantMarvao Medical Devices, Ltd.
Decision Date2017-11-30
Product CodeMSD
Advisory CommitteeGU
DecisionUnknown

Device Summary

NexSite HD, Hemodialysis Step Tip Catheter (60cm) is a medical device manufactured by Marvao Medical Devices, Ltd.. It received FDA 510(k) clearance on 2017-11-30 under approval number K171571. 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 NexSite HD, Hemodialysis Step Tip Catheter (60cm)?

NexSite HD, Hemodialysis Step Tip Catheter (60cm) is a medical device that received FDA 510(k) clearance on 2017-11-30. It is manufactured by Marvao Medical Devices, Ltd.. The 510(k) number is K171571.

When was NexSite HD, Hemodialysis Step Tip Catheter (60cm) approved by the FDA?

NexSite HD, Hemodialysis Step Tip Catheter (60cm) received FDA 510(k) clearance on 2017-11-30, under approval number K171571.

What company makes NexSite HD, Hemodialysis Step Tip Catheter (60cm)?

NexSite HD, Hemodialysis Step Tip Catheter (60cm) is manufactured by Marvao Medical Devices, Ltd..

What is the FDA product code for NexSite HD, Hemodialysis Step Tip Catheter (60cm)?

The FDA product code for NexSite HD, Hemodialysis Step Tip Catheter (60cm) is MSD.

Related Clinical Trials

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

Other Devices by Marvao Medical Devices, Ltd.

K161026NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm) 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) K220632Boss Crossing Support Catheter

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. 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. K182443Pristine Hemodialysis CatheterPristine Access Technologies , Ltd.

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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