510(k) · Cleared

Cleared

EN Snare Endovascular Snare System

K092343510(k) TraditionalCleared Aug 7, 20093-day reviewClass II21 CFR 870.5150

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Merit Medical Systems, Inc. · MMX Device, Percutaneous Retrieval

Cleared on Aug 7, 2009 as substantially equivalent to K021606 (Medical Device Technologies, Inc., 2002) after a 3-day review. Its family tree reaches back 3 generations to 1990. 1 of the 17 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it.

Decided: Aug 7, 2009
Review: 3 days
Class: Class II
Product code: MMX
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K901502 (1990). 7 ancestors in all. 9 later devices descend from it, 4 citing it directly. 1 of the 17 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 3 generations backK901502 Amplatz Goose-Neck SnareMicrovena Corp. · 1990 · Recalled
2 generations backK972511 Amplatz Goose Neck Snare Kit/ CatheterMicrovena Corp. · 1998 · Recalled
1 generation backK021606 EN-Snare Endovascular Snare and CatheterMedical Device Technologies, Inc. · 2002
This deviceK092343 EN Snare Endovascular Snare SystemMerit Medical Systems, Inc. · 2009
Descendant · cites it directly · 6 of its ownK112185 Foursnare Vascular Retrieval SnareCook, Inc. · 2011 · Recalled (Class I)
Descendant · cites it directly · 2 of its ownK151497 EN Snare Endovascular Snare SystemMerit Medical Systems, Inc. · 2015
Descendant · 2 generations on · 1 of its ownK222083 LimFlow V-CeiverLimFlow, Inc. · 2022
Descendant · cites it directly · 1 of its ownK170987 Captus Vascular Retrieval SystemAvantec Vascular Corporation · 2017
Descendant · 3 generations on · 0 of its ownK242776 LimFlow V-CeiverLimFlow, Inc. · 2025

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2011high 3 (2022) · low 0 (2012)2026

Class I recalls in this family

K112185 Foursnare Vascular Retrieval Snarecites it directly · 2011

Most influential descendants

Showing 5 of 9 · See all

K112185Foursnare Vascular Retrieval SnareCook, Inc. · 2011 · cites it directly6descendants
K151497EN Snare Endovascular Snare SystemMerit Medical Systems, Inc. · 2015 · cites it directly2descendants
K222083LimFlow V-CeiverLimFlow, Inc. · 2022 · 2 generations on1descendant
K170987Captus Vascular Retrieval SystemAvantec Vascular Corporation · 2017 · cites it directly1descendant
K242776LimFlow V-CeiverLimFlow, Inc. · 2025 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K901502	Amplatz Goose-Neck Snare	Microvena Corp.	1990	1
−2	K972511	Amplatz Goose Neck Snare Kit/ Catheter	Microvena Corp.	1998	1
−1	K021606	EN-Snare Endovascular Snare and Catheter	Medical Device Technologies, Inc.	2002	—
0 (this device)	K092343	EN Snare Endovascular Snare System	Merit Medical Systems, Inc.	2009	—
+1	K112185	Foursnare Vascular Retrieval Snare	Cook, Inc.	2011	Class I
+1	K151497	EN Snare Endovascular Snare System	Merit Medical Systems, Inc.	2015	—
+2	K222083	LimFlow V-Ceiver	LimFlow, Inc.	2022	—
+1	K170987	Captus Vascular Retrieval System	Avantec Vascular Corporation	2017	—
+3	K242776	LimFlow V-Ceiver	LimFlow, Inc.	2025	—

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
2011	1	1
2015	1	0
2016	2	0
2017	1	0
2022	3	0
2025	1	0

FIG. 1 — Lineage of K092343, 1990–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 11.0 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) 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	Applicant	Decided	Recalls
*	K021606	EN-Snare Endovascular Snare and Catheter Summary page 1 …on Name: Device, Percutaneous Retrieval Device Manufacturer: Medical Device Technologies, Inc Premarket Notification: K021606 Decision Date: 05/31/2002 Class 11 Classification Emnbolectorny Cathet…	Medical Device Technologies, Inc.	2002	—

Also cleared against K021606: 1 other device →

What descends from it? (9)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K112185	Foursnare Vascular Retrieval Snare Class I	Cook, Inc.	2011	6
K151497	EN Snare Endovascular Snare System	Merit Medical Systems, Inc.	2015	2
K170987	Captus Vascular Retrieval System	Avantec Vascular Corporation	2017	1
K213494	Aveir Retrieval Catheter	Abbott Medical	2022	0

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.

K112185Foursnare Vascular Retrieval SnareCook, Inc. · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
2 of the 7 ancestors have a recall of any class.
Of its descendants, K112185 (Cook, Inc., 2011) has gone furthest, with 6 descendants of its own.
1 other device also cites its predicate K021606.

How does its category compare?

All MMX devices

MMX Device, Percutaneous Retrieval: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · MMX

1in 2025

2007high 3 (2022) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MMX

151in 2022

2007high 151 (2022)2026

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

2007high 49 (2025) · low 2 (2007)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	MAUDE reports
2007	1	—	2
2008	0	—	6
2009	2	—	6
2010	1	—	11
2011	1	—	15
2012	1	—	13
2013	0	—	10
2014	2	—	11
2015	2	—	5
2016	2	—	16
2017	2	—	29
2018	1	—	15
2019	1	—	17
2020	2	—	14
2021	1	—	22
2022	3	151	37
2023	2	—	40
2024	1	—	32
2025	1	—	49
2026	0	—	—

What is it indicated for?

The EN Snare Endovascular Snare and Catheter is intended for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects. Manipulation procedures include indwelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access veni-puncture procedure assistance.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K092343 · printed Nov 4, 2026

Cite this page

510(k) Report. “K092343: EN Snare Endovascular Snare System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092343

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