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FDA 510(k)

NexSite 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)

K-Number: K173805 · 2018-02-08

ApplicantMarvao Medical Devices, Ltd.
Decision Date2018-02-08
Product CodeMSD
Advisory CommitteeGU
DecisionUnknown

Device Summary

NexSite 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) is a medical device manufactured by Marvao Medical Devices, Ltd.. It received FDA 510(k) clearance on 2018-02-08 under approval number K173805. 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 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)?

NexSite 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) is a medical device that received FDA 510(k) clearance on 2018-02-08. It is manufactured by Marvao Medical Devices, Ltd.. The 510(k) number is K173805.

When was NexSite 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) approved by the FDA?

NexSite 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) received FDA 510(k) clearance on 2018-02-08, under approval number K173805.

What company makes NexSite 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)?

NexSite 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) is manufactured by Marvao Medical Devices, Ltd..

What is the FDA product code for NexSite 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)?

The FDA product code for NexSite 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) 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) K171571NexSite HD, Hemodialysis Step Tip Catheter (60cm) 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. 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) K182443Pristine Hemodialysis CatheterPristine Access Technologies , 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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