PQK · Class II · 21 CFR 870.1252

FDA Product Code PQK: Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access

Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access. This Device Is A Single Use Percutaneous Catheter System That Creates An Arteriovenous Fistula In The Arm Of Patients With Chronic Kidney Disease Who Need Hemodialysis.

Leading manufacturers include Avenu Medical, Inc., C.R. Bard, Inc. and Tva Medical, Inc..

7
Total
5
Cleared
260d
Avg days
2018
Since

FDA 510(k) Cleared Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access Devices (Product Code PQK)

7 devices
1–7 of 7
Cleared Oct 17, 2019
WavelinQ Plus EndoAVF System
K192239
C.R. Bard, Inc.
Cardiovascular · 59d
Cleared Aug 09, 2019
Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle
K191114
Avenu Medical
Cardiovascular · 105d
Cleared Feb 06, 2019
WavelinQ 4F EndoAVF System
K182796
C.R. Bard, Inc.
Cardiovascular · 128d
Cleared Jan 25, 2019
Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle
K183615
Avenu Medical, Inc.
Cardiovascular · 30d
Cleared Oct 05, 2018
Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)
K181725
Avenu Medical, Inc.
Cardiovascular · 98d
Not Cleared Jun 22, 2018
everlinQ endoAVF System
DEN160006
Tva Medical, Inc.
Cardiovascular · 870d
Not Cleared Jun 22, 2018
Ellipsys Vascular Access System
DEN170004
Avenu Medical, Inc.
Cardiovascular · 528d

About Product Code PQK - Regulatory Context