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FDA 510(k)

WavelinQ Plus EndoAVF System

K-Number: K192239 · 2019-10-17

ApplicantC.R. Bard, Inc.
Decision Date2019-10-17
Product CodePQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WavelinQ Plus EndoAVF System is a medical device manufactured by C.R. Bard, Inc.. It received FDA 510(k) clearance on 2019-10-17 under approval number K192239. The device is classified under product code PQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WavelinQ Plus EndoAVF System?

WavelinQ Plus EndoAVF System is a medical device that received FDA 510(k) clearance on 2019-10-17. It is manufactured by C.R. Bard, Inc.. The 510(k) number is K192239.

When was WavelinQ Plus EndoAVF System approved by the FDA?

WavelinQ Plus EndoAVF System received FDA 510(k) clearance on 2019-10-17, under approval number K192239.

What company makes WavelinQ Plus EndoAVF System?

WavelinQ Plus EndoAVF System is manufactured by C.R. Bard, Inc..

What is the FDA product code for WavelinQ Plus EndoAVF System?

The FDA product code for WavelinQ Plus EndoAVF System is PQK.

Related Clinical Trials

NCT04634916 Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System RECRUITING

Other Devices by C.R. Bard, Inc.

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Related Devices (Code: PQK)

K181725Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)Avenu Medical, Inc. DEN160006everlinQ endoAVF SystemTva Medical, Inc. DEN170004Ellipsys Vascular Access SystemAvenu Medical, Inc. K191114Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), NeedleAvenu Medical K182796WavelinQ 4F EndoAVF SystemC.R. Bard, Inc. K183615Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing NeedleAvenu Medical, Inc.

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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