WavelinQ Plus EndoAVF System
FDA 510(k) K192239 · C.R. Bard, Inc.
510(k) numberK192239
Submission
- Device name
- WavelinQ Plus EndoAVF System
- Applicant
- C.R. Bard, Inc.
Tempe, AZ, US - Received
- August 19, 2019
- Decision date
- October 17, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PQK – Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1252
- Specialty
- Cardiovascular
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.
Other 510(k)s with product code PQK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K191114 | Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular…PQK · Traditional | Avenu Medical | 08/09/2019SE |
| K182796 | WavelinQ 4F EndoAVF SystemPQK · Traditional | C.R. Bard, Inc. | 02/06/2019SE |
| K183615 | Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular…PQK · Special | Avenu Medical, Inc. | 01/25/2019SE |
| K181725 | Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001…PQK · Traditional | Avenu Medical, Inc. | 10/05/2018SE |
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| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)LDF · Special | 05/15/2025SE |
| K241334 | Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes…LDF · Traditional | 01/31/2025SE |
| K230356 | Aspirex Thrombectomy SystemQEW · Traditional | 03/31/2023SE |
| K223177 | Highlander 014 PTA Balloon Dilatation CatheterLIT · Traditional | 01/20/2023SE |
| K222793 | WavelinQ GeneratorGEI · Special | 10/17/2022SE |
| K220270 | Aspirex Thrombectomy SystemQEW · Traditional | 06/21/2022SE |
Questions and answers
When was WavelinQ Plus EndoAVF System cleared by the FDA?
WavelinQ Plus EndoAVF System (K192239) received a 510(k) decision of Substantially Equivalent on October 17, 2019, 59 days after the submission was received.
What is the product code of K192239?
The FDA product code is PQK – Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access, a Class II (moderate risk) device regulated under 21 CFR 870.1252.