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FDA 510(k)

WavelinQ 4F EndoAVF System

K-Number: K182796 · 2019-02-06

ApplicantC.R. Bard, Inc.
Decision Date2019-02-06
Product CodePQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WavelinQ 4F EndoAVF System is a medical device manufactured by C.R. Bard, Inc.. It received FDA 510(k) clearance on 2019-02-06 under approval number K182796. 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 4F EndoAVF System?

WavelinQ 4F EndoAVF System is a medical device that received FDA 510(k) clearance on 2019-02-06. It is manufactured by C.R. Bard, Inc.. The 510(k) number is K182796.

When was WavelinQ 4F EndoAVF System approved by the FDA?

WavelinQ 4F EndoAVF System received FDA 510(k) clearance on 2019-02-06, under approval number K182796.

What company makes WavelinQ 4F EndoAVF System?

WavelinQ 4F EndoAVF System is manufactured by C.R. Bard, Inc..

What is the FDA product code for WavelinQ 4F EndoAVF System?

The FDA product code for WavelinQ 4F 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.

K162900PowerMidline Catheter K162894AccuCath Intravascular Catheter K162769Pinpoint GT Introducer Needle K162443PowerPICC Provena Catheters K161424Phasix Mesh K162377PowerGlide Pro Midline Catheter

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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. K192239WavelinQ Plus EndoAVF SystemC.R. Bard, Inc. K191114Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), NeedleAvenu Medical 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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