510(k) · Cleared
ClearedEN Snare Endovascular Snare System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Systems, Inc. · MMX Device, Percutaneous Retrieval
Cleared on Jul 1, 2015 as substantially equivalent to K092343 (Merit Medical Systems, Inc., 2009) after a 27-day review. Its family tree reaches back 4 generations to 1990. 2 later devices descend from it.
- Decided
- Jul 1, 2015
- Review
- 27 days
- Class
- Class II
- Product code
- MMX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K901502 (1990). 8 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK901502 Amplatz Goose-Neck SnareMicrovena Corp. · 1990 · Recalled
- 3 generations backK972511 Amplatz Goose Neck Snare Kit/ CatheterMicrovena Corp. · 1998 · Recalled
- 2 generations backK021606 EN-Snare Endovascular Snare and CatheterMedical Device Technologies, Inc. · 2002
- 1 generation backK092343 EN Snare Endovascular Snare SystemMerit Medical Systems, Inc. · 2009
- This deviceK151497 EN Snare Endovascular Snare SystemMerit Medical Systems, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK170987 Captus Vascular Retrieval SystemAvantec Vascular Corporation · 2017
- Descendant · 2 generations on · 0 of its ownK212988 ONO Retrieval DeviceOnocor Vascular, LLC · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K901502 | Amplatz Goose-Neck Snare | Microvena Corp. | 1990 | 1 |
| −3 | K972511 | Amplatz Goose Neck Snare Kit/ Catheter | Microvena Corp. | 1998 | 1 |
| −2 | K021606 | EN-Snare Endovascular Snare and Catheter | Medical Device Technologies, Inc. | 2002 | — |
| −1 | K092343 | EN Snare Endovascular Snare System | Merit Medical Systems, Inc. | 2009 | — |
| 0 (this device) | K151497 | EN Snare Endovascular Snare System | Merit Medical Systems, Inc. | 2015 | — |
| +1 | K170987 | Captus Vascular Retrieval System | Avantec Vascular Corporation | 2017 | — |
| +2 | K212988 | ONO Retrieval Device | Onocor Vascular, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2022 | 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 MMX? 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? (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 |
|---|---|---|---|
| * | K092343 | EN Snare Endovascular Snare SystemSummary page 4…e Name: EN Snare Endovascular Snare System Classification Name: Device, Percutaneous Retrieval Premarket Notification: K092343 Manufacturer: Merit Medical Systems, Inc. Predicate Device Reference Device… | 2009 |
| † | K122088 | Merit One Snare System | 2012 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170987 | Captus Vascular Retrieval System | 2017 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K170987 (Avantec Vascular Corporation, 2017) has gone furthest, with 1 descendant of its own.
- 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. 2015, 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 EN Snare Endovascular Snare System is intended for use in the coronary and peripheral vascular system or hollow viscous to retrieve and manipulate foreign objects. Retrieval and manipulation procedures include, indwelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access venipuncture procedure assistance.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151497 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151497: EN Snare Endovascular Snare System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151497
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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