510(k) · Cleared
ClearedEN-Snare Endovascular Snare and Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Device Technologies, Inc. · MMX Device, Percutaneous Retrieval
Cleared on May 31, 2002 as substantially equivalent to K970668 (Microvena Corp., 1998) and 1 other predicate after a 15-day review. Its family tree reaches back 2 generations to 1990. 1 of the 18 devices in its family, counting itself, has a Class I recall. 11 later devices descend from it.
- Decided
- May 31, 2002
- Review
- 15 days
- Class
- Class II
- Product code
- MMX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K901502 (1990). 6 ancestors in all. 11 later devices descend from it, 2 citing it directly. 1 of the 18 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK901502 Amplatz Goose-Neck SnareMicrovena Corp. · 1990 · Recalled
- 1 generation backK972511 Amplatz Goose Neck Snare Kit/ CatheterMicrovena Corp. · 1998 · Recalled
- This deviceK021606 EN-Snare Endovascular Snare and CatheterMedical Device Technologies, Inc. · 2002
- Descendant · cites it directly · 9 of its ownK092343 EN Snare Endovascular Snare SystemMerit Medical Systems, Inc. · 2009
- Descendant · 2 generations on · 6 of its ownK112185 Foursnare Vascular Retrieval SnareCook, Inc. · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK151497 EN Snare Endovascular Snare SystemMerit Medical Systems, Inc. · 2015
- Descendant · 3 generations on · 1 of its ownK222083 LimFlow V-CeiverLimFlow, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK170987 Captus Vascular Retrieval SystemAvantec Vascular Corporation · 2017
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K112185 Foursnare Vascular Retrieval Snare2 generations on · 2011
Most influential descendants
Showing 5 of 11 · See all- K092343EN Snare Endovascular Snare SystemMerit Medical Systems, Inc. · 2009 · cites it directly9descendants
- K112185Foursnare Vascular Retrieval SnareCook, Inc. · 2011 · 2 generations on6descendants
- K151497EN Snare Endovascular Snare SystemMerit Medical Systems, Inc. · 2015 · 2 generations on2descendants
- K222083LimFlow V-CeiverLimFlow, Inc. · 2022 · 3 generations on1descendant
- K170987Captus Vascular Retrieval SystemAvantec Vascular Corporation · 2017 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K901502 | Amplatz Goose-Neck Snare | Microvena Corp. | 1990 | 1 |
| −1 | K972511 | Amplatz Goose Neck Snare Kit/ Catheter | Microvena Corp. | 1998 | 1 |
| 0 (this device) | K021606 | EN-Snare Endovascular Snare and Catheter | Medical Device Technologies, Inc. | 2002 | — |
| +1 | K092343 | EN Snare Endovascular Snare System | Merit Medical Systems, Inc. | 2009 | — |
| +2 | K112185 | Foursnare Vascular Retrieval Snare | Cook, Inc. | 2011 | Class I |
| +2 | K151497 | EN Snare Endovascular Snare System | Merit Medical Systems, Inc. | 2015 | — |
| +3 | K222083 | LimFlow V-Ceiver | LimFlow, Inc. | 2022 | — |
| +2 | K170987 | Captus Vascular Retrieval System | Avantec Vascular Corporation | 2017 | — |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 1 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2022 | 3 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K970668 | The Amplantz Goose Neck MicrosnareSummary page 1…ular Snare and Catheter Intravascular snare and catheter Percutaneous Catheter, 21 CFR 870.1250 78 DQY Cardiovascular Product Name 510(k) No. Amplatz Goose Neck Snare K970668 and K972511 The En-Snare™ Endovascular Snare and Catheter is comprised of stranded nitinol/platinum cables mechanically secured… | 1998 |
| * | K972511 | Amplatz Goose Neck Snare Kit/ CatheterSummary page 1…nd Catheter Intravascular snare and catheter Percutaneous Catheter, 21 CFR 870.1250 78 DQY Cardiovascular Product Name 510(k) No. Amplatz Goose Neck Snare K970668 and K972511 The En-Snare™ Endovascular Snare and Catheter is comprised of stranded nitinol/platinum cables mechanically secured to a nitinol… | 1998 |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 7.3 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K092343 (Merit Medical Systems, Inc., 2009) has gone furthest, with 9 descendants of its own.
- 4 other devices also cite its predicate K970668.
How does its category compare?
All MMX devicesMMX Device, Percutaneous Retrieval: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K021606 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021606: EN-Snare Endovascular Snare and Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021606
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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