FDA 510(k)

WavelinQ 4F EndoAVF System

K-Number: K182796 · 2019-02-06

Decision Date2019-02-06

Product CodePQK

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

WavelinQ 4F EndoAVF System is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2019-02-06 under 510(k) 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. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K182796.

When did WavelinQ 4F EndoAVF System receive FDA 510(k) clearance?

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

Who is the listed applicant for WavelinQ 4F EndoAVF System?

The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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Related Devices (Code: PQK)

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.K181725Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)Avenu 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.