510(k) · Cleared

Cleared

Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval Set

K073374510(k) TraditionalCleared Mar 7, 200895-day reviewClass II21 CFR 870.3375

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

William Cook Europe Aps · DTK Filter, Intravascular, Cardiovascular

Cleared on Mar 7, 2008 as substantially equivalent to K061815 (William Cook Europe Aps, 2007) and 1 other predicate after a 95-day review. Its family tree reaches back 5 generations to 1990. 2 of the 29 devices in its family, counting itself, have a Class I recall. 16 later devices descend from it.

Decided: Mar 7, 2008
Review: 95 days
Class: Class II
Product code: DTK
Recalls: None
Predicates: 2

Its longest line of descent runs back 5 generations to K901502 (1990). 12 ancestors in all. 16 later devices descend from it, 6 citing it directly. 2 of the 29 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 5 generations backK901502 Amplatz Goose-Neck SnareMicrovena Corp. · 1990 · Recalled
4 generations backK972511 Amplatz Goose Neck Snare Kit/ CatheterMicrovena Corp. · 1998 · Recalled
3 generations backK021441 Radius SnareRadius Medical Technologies, Inc. · 2002
2 generations backK022201 Radius Micro SnareRadius Medical Technologies, Inc. · 2003
1 generation backK032426 Gunhter Tulip Vena Cava Mreye Filter and Retrieval SetCook, Inc. · 2003
This deviceK073374 Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter…William Cook Europe Aps · 2008
Descendant · cites it directly · 6 of its ownK112185 Foursnare Vascular Retrieval SnareCook, Inc. · 2011 · Recalled (Class I)
Descendant · cites it directly · 2 of its ownK152560 Bard Snare Retrieval KitNeometrics, Inc. · 2015
Descendant · 2 generations on · 1 of its ownK222083 LimFlow V-CeiverLimFlow, Inc. · 2022
Descendant · 2 generations on · 1 of its ownK191758 Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval KitArgon Medical Devices, Inc. · 2019
Descendant · cites it directly · 1 of its ownK181757 Günther Tulip® Vena Cava Filter Retrieval SetCook Incorporated · 2018

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2011high 3 (2016) · low 0 (2013)2026

Class I recalls in this family

K970466 Radius Ptca Guidewire3 generations back · 1997
K112185 Foursnare Vascular Retrieval Snarecites it directly · 2011

Most influential descendants

Showing 5 of 16 · See all

K112185Foursnare Vascular Retrieval SnareCook, Inc. · 2011 · cites it directly6descendants
K152560Bard Snare Retrieval KitNeometrics, Inc. · 2015 · cites it directly2descendants
K222083LimFlow V-CeiverLimFlow, Inc. · 2022 · 2 generations on1descendant
K191758Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval KitArgon Medical Devices, Inc. · 2019 · 2 generations on1descendant
K181757Günther Tulip® Vena Cava Filter Retrieval SetCook Incorporated · 2018 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K901502	Amplatz Goose-Neck Snare	Microvena Corp.	1990	1
−4	K972511	Amplatz Goose Neck Snare Kit/ Catheter	Microvena Corp.	1998	1
−3	K021441	Radius Snare	Radius Medical Technologies, Inc.	2002	—
−2	K022201	Radius Micro Snare	Radius Medical Technologies, Inc.	2003	—
−1	K032426	Gunhter Tulip Vena Cava Mreye Filter and Retrieval Set	Cook, Inc.	2003	—
0 (this device)	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
+1	K152560	Bard Snare Retrieval Kit	Neometrics, Inc.	2015	—
+2	K222083	LimFlow V-Ceiver	LimFlow, Inc.	2022	—
+2	K191758	Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit	Argon Medical Devices, Inc.	2019	—
+1	K181757	Günther Tulip® Vena Cava Filter Retrieval Set	Cook Incorporated	2018	—

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
2007	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	1
2012	1	0
2014	1	0
2015	1	0
2016	3	0
2017	1	0
2018	1	0
2019	1	0
2022	3	0
2023	2	0
2025	1	0

FIG. 1 — Lineage of K073374, 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.

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 DTK device

#1 K242612 Option ELITE Vena Cava Filter System…score 10.1 · 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? (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	Applicant	Decided	Recalls
*	K061815	Cook Celect Vena Cava Filter Summary page 1 …elect Vena Cava Filter Set with its expanded indications for use statement is substantially equivalent (identical) to the Cook Celect Vena Cava Filter (D.C.# K061 815, cleared on 20 April 2007). AORTIC INTERVENTION CARDIOLOGY CRITICAL CARE ENDOSCOPY PER PHERAL INTERVENTIO…	William Cook Europe Aps	2007	—
*	K032426	Gunhter Tulip Vena Cava Mreye Filter and Retrieval Set Summary page 2 …Filter Retrieval Set with its expanded indications for use statement is substantially equivalent (identical) to the Gfinther Tulip Vena Cava Filter Retrieval Set (D.C.# K032426, cleared on October 31, 2003). 4. Device Description: The Cook Celect Vena Cava Filter is an inferior vena cava filter intended…	Cook, Inc.	2003	—

What descends from it? (16)

See all 16

6 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
K152560	Bard Snare Retrieval Kit	Neometrics, Inc.	2015	2
K181757	Günther Tulip® Vena Cava Filter Retrieval Set	Cook Incorporated	2018	1
K133681	Crux Snare Filter Retrieval Set	Volcano Corporation	2014	1
K160747	Angel Catheter	Bio2 Medical, Inc.	2016	0
K121629	Cook Celect Platinum Vena Cava Filter Set for Femoral Approach Cook Celect Platium Vena…	William Cook Europe Aps	2012	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.

K970466Radius Ptca GuidewireRadius Medical Technologies, Inc. · 1997 · 3 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls
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 18 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
3 of the 12 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K112185 (Cook, Inc., 2011) has gone furthest, with 6 descendants of its own.

How does its category compare?

All DTK devices

DTK Filter, Intravascular, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · DTK

5in 2024

2007high 6 (2008) · low 0 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTK

29in 2024

2007high 380 (2009) · low 29 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DTK

1in 2025

2007high 6 (2019) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DTK

432in 2025

2007high 6,467 (2019) · low 345 (2008)2025

MAUDE reports naming product code DTK, 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	3	87	1	364
2008	6	87	0	345
2009	3	380	0	456
2010	3	50	0	369
2011	2	—	0	439
2012	5	156	0	351
2013	3	91	1	473
2014	2	—	0	451
2015	2	—	1	859
2016	3	84	2	2,574
2017	5	88	0	4,364
2018	2	—	0	3,938
2019	0	—	6	6,467
2020	0	—	0	5,405
2021	2	—	0	5,357
2022	0	—	2	2,191
2023	0	—	0	583
2024	5	29	0	406
2025	0	—	1	432
2026	0	—	0	—

What is it indicated for?

The Cook CelectTM Vena Cava Filter is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations: * Pulmonary thromboembolism when anticoagulant therapy is contraindicated; * Failure of anticoagulant therapy in thromboembolic diseases; * Emergency treatment following massive pulmonary embolism when anticipated benefits of conventional therapy are reduced; and * Chronic, recurrent pulmonary…

Read the full statement (130 words)

The Cook CelectTM Vena Cava Filter is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations:

* Pulmonary thromboembolism when anticoagulant therapy is contraindicated;

* Failure of anticoagulant therapy in thromboembolic diseases;

* Emergency treatment following massive pulmonary embolism when anticipated benefits of conventional therapy are reduced; and

* Chronic, recurrent pulmonary embolism when anticoagulant therapy has failed or is contraindicated.

The filter may be retrieved according to the instructions supplied in the section labeled "Optional Retrieval Procedure."

The Günther TulipTM Vena Cava Filter Retrieval Set has been designed for retrieval of implanted Günther TulipTM and Cook CelectTM Vena Cava Filters in patients who no longer require a filter. Retrieval of the filter can be performed only by jugular approach.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K073374 · printed Nov 6, 2026

Cite this page

510(k) Report. “K073374: Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073374

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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