510(k) · Cleared
Recalled · Class II · 2019WavelinQ 4F EndoAVF System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · PQK Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
Cleared on Feb 6, 2019 as substantially equivalent to DEN160006 (Tva Medical, Inc., 2018) after a 128-day review. Its family tree reaches back 1 generation to 2018. 1 later device descends from it. It has been recalled once.
- Decided
- Feb 6, 2019
- Review
- 128 days
- Class
- Class II
- Product code
- PQK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN160006 (2018). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K192239WavelinQ Plus EndoAVF SystemC.R. Bard, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN160006 | everlinQ endoAVF System | Tva Medical, Inc. | 2018 | — |
| 0 (this device) | K182796 | WavelinQ 4F EndoAVF System | C.R. Bard, Inc. | 2019 | — |
| +1 | K192239 | WavelinQ Plus EndoAVF System | C.R. Bard, Inc. | 2019 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PQK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN160006 | everlinQ endoAVF SystemSummary page 4…Review Panel: Cardiovascular Regulation Number: 21 CFR 870.1252 Predicate Device: Device Trade Name: everlinQ® endoAVF System (DEN160006) Common or Usual Name: Percutaneous catheter for creation of an arteriovenous fistula for… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192239 | WavelinQ Plus EndoAVF System | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 12, 2019 | Class II | Z-1637-2020 | Nonconforming Material/Component | The firm has become aware of a potential problem with their venous and arterial magnetic catheters may be at risk of experiencing a magnetic deficiency, which may result in the magnets failing to attract to one another. This may result in… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K192239 (C.R. Bard, Inc., 2019) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PQK devicesPQK Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · PQK
4in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · PQK
82in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PQK
No recall names PQK since 2007.
Adverse event reports per year · PQK
44in 2025
MAUDE reports naming product code PQK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 3 | — | 0 | 3 |
| 2019 | 4 | 82 | 0 | 51 |
| 2020 | 0 | — | 0 | 61 |
| 2021 | 0 | — | 0 | 74 |
| 2022 | 0 | — | 0 | 77 |
| 2023 | 0 | — | 0 | 71 |
| 2024 | 0 | — | 0 | 78 |
| 2025 | 0 | — | 0 | 44 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The WavelinQ 4F EndoAVF System is indicated for the creation of an arteriovenous fistula (AVF) using concomitant ulnar artery and ulnar vein or concomitant radial artery and radial vein in patients with minimum artery and vein diameters of 2.0 mm at the fistula creation site who have chronic kidney disease and need hemodialysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182796 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182796: WavelinQ 4F EndoAVF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182796
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026