510(k) · Cleared
ClearedAveir Retrieval Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Medical · MMX Device, Percutaneous Retrieval
Cleared on Apr 1, 2022 as substantially equivalent to K092343 (Merit Medical Systems, Inc., 2009) and 2 other predicates after a 151-day review. Its family tree reaches back 7 generations to 1990. 1 of the 18 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 1, 2022
- Review
- 151 days
- Class
- Class II
- Product code
- MMX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K901502 (1990). 17 ancestors in all. No later device cites it as a predicate yet. 1 of the 18 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK901502 Amplatz Goose-Neck SnareMicrovena Corp. · 1990 · Recalled
- 6 generations backK972511 Amplatz Goose Neck Snare Kit/ CatheterMicrovena Corp. · 1998 · Recalled
- 5 generations backK021441 Radius SnareRadius Medical Technologies, Inc. · 2002
- 4 generations backK022201 Radius Micro SnareRadius Medical Technologies, Inc. · 2003
- 3 generations backK032426 Gunhter Tulip Vena Cava Mreye Filter and Retrieval SetCook, Inc. · 2003
- 2 generations backK073374 Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter…William Cook Europe Aps · 2008
- 1 generation backK133681 Crux Snare Filter Retrieval SetVolcano Corporation · 2014
- This deviceK213494 Aveir Retrieval CatheterAbbott Medical · 2022
Class I recalls in this family
- K970466 Radius Ptca Guidewire5 generations back · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K901502 | Amplatz Goose-Neck Snare | Microvena Corp. | 1990 | 1 |
| −6 | K972511 | Amplatz Goose Neck Snare Kit/ Catheter | Microvena Corp. | 1998 | 1 |
| −5 | K021441 | Radius Snare | Radius Medical Technologies, Inc. | 2002 | — |
| −4 | K022201 | Radius Micro Snare | Radius Medical Technologies, Inc. | 2003 | — |
| −3 | K032426 | Gunhter Tulip Vena Cava Mreye Filter and Retrieval Set | Cook, Inc. | 2003 | — |
| −2 | K073374 | Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval Set | William Cook Europe Aps | 2008 | — |
| −1 | K133681 | Crux Snare Filter Retrieval Set | Volcano Corporation | 2014 | — |
| 0 (this device) | K213494 | Aveir Retrieval Catheter | Abbott Medical | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1997 | 1 | 1 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 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.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MMX device
- #1 K242776 LimFlow V-Ceiverscore 10.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K092343 | EN Snare Endovascular Snare SystemSummary page 5…CE The Aveir™ Retrieval Catheter is substantially equivalent in intended use and method of operation to the predicate devices listed below: x 510(k) K092343: Merit Medical, EN Snare® Endovascular Snare System x 510(k) K122088: Merit Medical, One Snare® Endovascular Snare System… | 2009 |
| * | K122088 | Merit One Snare SystemSummary page 5…ed use and method of operation to the predicate devices listed below: x 510(k) K092343: Merit Medical, EN Snare® Endovascular Snare System x 510(k) K122088: Merit Medical, One Snare® Endovascular Snare System x 510(k) K133681: Volcano Corporation, Crux® Snare Filter Retrieval… | 2012 |
| * | K133681 | Crux Snare Filter Retrieval SetSummary page 5…x 510(k) K092343: Merit Medical, EN Snare® Endovascular Snare System x 510(k) K122088: Merit Medical, One Snare® Endovascular Snare System x 510(k) K133681: Volcano Corporation, Crux® Snare Filter Retrieval Set V. DEVICE DESCRIPTION The Aveir™ Retrieval Catheter, model LSC… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K970466Radius Ptca GuidewireRadius Medical Technologies, Inc. · 1997 · 5 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 32 years and passes through 6 companies; a new generation was cleared every 4.4 years on median.
- 3 of the 17 ancestors have a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K092343.
How does its category compare?
All MMX devicesMMX Device, Percutaneous Retrieval: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · MMX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MMX
151in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MMX
No recall names MMX since 2007.
Adverse event reports per year · MMX
49in 2025
MAUDE reports naming product code MMX, 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 | 1 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 6 |
| 2009 | 2 | — | 0 | 6 |
| 2010 | 1 | — | 0 | 11 |
| 2011 | 1 | — | 0 | 15 |
| 2012 | 1 | — | 0 | 13 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 2 | — | 0 | 11 |
| 2015 | 2 | — | 0 | 5 |
| 2016 | 2 | — | 0 | 16 |
| 2017 | 2 | — | 0 | 29 |
| 2018 | 1 | — | 0 | 15 |
| 2019 | 1 | — | 0 | 17 |
| 2020 | 2 | — | 0 | 14 |
| 2021 | 1 | — | 0 | 22 |
| 2022 | 3 | 151 | 0 | 37 |
| 2023 | 2 | — | 0 | 40 |
| 2024 | 1 | — | 0 | 32 |
| 2025 | 1 | — | 0 | 49 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Aveir Retrieval Catheter is intended to be used in the peripheral vasculature and the cardiovascular system to retrieve and manipulate an Abbott Medical leadless pacemaker (LP). Retrieval and manipulation includes removing the LP from the heart or peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213494 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213494: Aveir Retrieval Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213494
Report an extraction error
Are you the manufacturer?
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