510(k) · Cleared

Cleared

Captus Vascular Retrieval System

K170987510(k) TraditionalCleared Aug 28, 2017147-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

Avantec Vascular Corporation · MMX Device, Percutaneous Retrieval

Cleared on Aug 28, 2017 as substantially equivalent to K112185 (Cook, Inc., 2011) and 2 other predicates after a 147-day review. Its family tree reaches back 7 generations to 1990. 2 of the 19 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.

Decided: Aug 28, 2017
Review: 147 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. 1 later device descends from it, 1 citing it directly. 2 of the 19 devices in this family, counting this one, have a Class I recall.

By dateBy generation

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 backK112185 Foursnare Vascular Retrieval SnareCook, Inc. · 2011 · Recalled (Class I)
This deviceK170987 Captus Vascular Retrieval SystemAvantec Vascular Corporation · 2017
Descendant · cites it directly · 0 of its ownK212988 ONO Retrieval DeviceOnocor Vascular, LLC · 2022

Class I recalls in this family

K112185 Foursnare Vascular Retrieval Snaredirect predicate · 2011
K970466 Radius Ptca Guidewire5 generations back · 1997

Most influential descendants

Showing 1 of 1 · See all

K212988ONO Retrieval DeviceOnocor Vascular, LLC · 2022 · cites it directly0descendants

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	K112185	Foursnare Vascular Retrieval Snare	Cook, Inc.	2011	Class I
0 (this device)	K170987	Captus Vascular Retrieval System	Avantec Vascular Corporation	2017	—
+1	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
1997	1	1
1998	1	0
2000	1	0
2002	1	0
2007	1	0
2009	1	0
2015	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2022	1	0

FIG. 1 — Lineage of K170987, 1990–2022Source: 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.

2 devices in this family have 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

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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	Applicant	Decided	Recalls
*	K112185	Foursnare Vascular Retrieval Snare Summary page 5 …Device Name / Manufacturer Primary Number Predicate K112185 FourSnare Vascular Retrieval Snare / Cook Inc.  K092343 EN Snare Endovascular Snare Sy…	Cook, Inc.	2011	Class I
*	K092343	EN Snare Endovascular Snare System Summary page 5 …Predicate K112185 FourSnare Vascular Retrieval Snare / Cook Inc.  K092343 EN Snare Endovascular Snare System / Merit Medical Systems, Inc. K151497 EN Snare Endovascular Snare System / Merit Med…	Merit Medical Systems, Inc.	2009	—
*	K151497	EN Snare Endovascular Snare System Summary page 5 …12185 FourSnare Vascular Retrieval Snare / Cook Inc.  K092343 EN Snare Endovascular Snare System / Merit Medical Systems, Inc. K151497 EN Snare Endovascular Snare System / Merit Medical Systems, Inc. SUMMARY OF NON-CLINICAL TESTING No FDA performance standar…	Merit Medical Systems, Inc.	2015	—

Also cleared against K112185: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K212988	ONO Retrieval Device	Onocor Vascular, LLC	2022	0

Has anything in its family been recalled? (2 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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
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 27 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
4 of the 17 ancestors have a recall of any class; 2 have a Class I recall.
Of its descendants, K212988 (Onocor Vascular, LLC, 2022) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K112185.

How does its category compare?

All MMX devices

MMX Device, Percutaneous Retrieval: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Captus Vascular Retrieval System is intended for use in the cardiovascular system to retrieve foreign objects, including, but not limited to guide wires, coils, balloons, catheters, and filters.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K170987 · printed Nov 4, 2026

Cite this page

510(k) Report. “K170987: Captus Vascular Retrieval System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K170987

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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