510(k) Report

510(k) · Cleared

Cleared

Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP); Günther Tulip Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-TULIP); Günther Tulip Vena Cava Filter

K233680510(k) TraditionalCleared Jan 18, 202463-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 Jan 18, 2024 as substantially equivalent to K211875 (William Cook Europe Aps, 2021) and 1 other predicate after a 63-day review. Its family tree reaches back 3 generations to 2009.

Decided
Jan 18, 2024
Review
63 days
Class
Class II
Product code
DTK
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K090140 (2009). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2021: 1 other ancestor2017: 1 other ancestorK090140 · Gunther Tulip Vena Cava Filter, Cook Celect Vena Cava Filter · William Cook Europe Aps · 2009K172557 · Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach · William Cook Europe Aps · 2017 · recalledK211874 · Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach · William Cook Europe Aps · 2021 · recalled20052010201520202025
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor K211874 · Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach · William Cook Europe Aps · 2021 · recalledK172557 · Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach · William Cook Europe Aps · 2017 · recalledK090140 · Gunther Tulip Vena Cava Filter, Cook Celect Vena Cava Filter · William Cook Europe Aps · 20090
  1. Root · 3 generations backK090140 Gunther Tulip Vena Cava Filter, Cook Celect Vena Cava FilterWilliam Cook Europe Aps · 2009
  2. 2 generations backK172557 Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach…William Cook Europe Aps · 2017 · Recalled
  3. 1 generation backK211874 Günther Tulip Vena Cava Filter Set for Femoral Vein Approach…William Cook Europe Aps · 2021 · Recalled
  4. This deviceK233680 Celect Platinum Vena Cava Filter Set for Femoral Vein Approach…William Cook Europe Aps · 2024
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K090140Gunther Tulip Vena Cava Filter, Cook Celect Vena Cava FilterWilliam Cook Europe Aps2009—
−2K172557Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip…William Cook Europe Aps20173
−1K211874Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip…William Cook Europe Aps20211
0 (this device)K233680Celect Platinum Vena Cava Filter Set for Femoral Vein Approach…William Cook Europe Aps2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
201710
202110
FIG. 1 — Lineage of K233680, 2009–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 DTK? 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. #1 K242612 Option ELITE Vena Cava Filter System…score 10.1 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K211875Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect…
Summary page 5
…Product Code: 21 CFR Part 870.3375 / DTK Classification/Panel: Class II / Cardiovascular Predicate Devices: The Cook Celect Platinum Vena Cava Filter Sets (K211875, cleared 28 July 2021) and the Günther Tulip Vena Cava Filter Sets (K211874, cleared 28 July 2021).…
William Cook Europe Aps20211
*K211874Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava…
Summary page 5
…ss II / Cardiovascular Predicate Devices: The Cook Celect Platinum Vena Cava Filter Sets (K211875, cleared 28 July 2021) and the Günther Tulip Vena Cava Filter Sets (K211874, cleared 28 July 2021).…
William Cook Europe Aps20211

What descends from it?

No later submission names this one as a predicate yet.

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 15 years and passes through 1 company; a new generation was cleared every 3.7 years on median.
  • 4 of the 5 ancestors have a recall of any class.

How does its category compare?

All DTK devices

DTK Filter, Intravascular, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · DTK

5in 2024

2007: 32008: 62009: 32010: 32011: 22012: 52013: 32014: 22015: 22016: 32017: 52018: 22021: 22024: 5
2007high 6 (2008) · low 0 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTK

29in 2024

2007: 87 days median2008: 87 days median2009: 380 days median2010: 50 days median2012: 156 days median2013: 91 days median2016: 84 days median2017: 88 days median2024: 29 days median
2007high 380 (2009) · low 29 (2024)2026

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

Recalls per year · DTK

1in 2025

2007: 12013: 12015: 12016: 22019: 62022: 22025: 1
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

2007: 3642008: 3452009: 4562010: 3692011: 4392012: 3512013: 4732014: 4512015: 8592016: 2,5742017: 4,3642018: 3,9382019: 6,4672020: 5,4052021: 5,3572022: 2,1912023: 5832024: 4062025: 432
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20073871364
20086870345
200933800456
20103500369
20112—0439
201251560351
20133911473
20142—0451
20152—1859
201638422,574
201758804,364
20182—03,938
20190—66,467
20200—05,405
20212—05,357
20220—22,191
20230—0583
20245290406
20250—1432
20260—0—

What is it indicated for?

The Gunther Tulip Filter implant 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 PE where anticipated benefits of conventional therapy are reduced; and • Chronic, recurrent PE where anticoagulant…

Read the full statement (238 words)

The Gunther Tulip Filter implant 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 PE where anticipated benefits of conventional therapy are

reduced; and

• Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated.

The Gunther Tulip Filter implant may be retrieved if clinically indicated; please refer to the "Optional

Filter Retrieval" section of the Instructions for Use for more information.

The product is intended for percutaneous placement via a femoral or jugular vein for filtration of

inferior vena cava (IVC) blood to prevent PE.

The Celect Platinum Filter implant 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 PE where anticipated benefits of conventional therapy are

reduced; and

• Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated.

The Celect Platinum Filter implant may be retrieved if clinically indicated; please refer to the

"Optional Filter Retrieval" section of the Instructions for Use for more information.

The product is intended for percutaneous placement via a femoral or jugular vein for filtration of

inferior vena cava (IVC) blood to prevent PE.

Indications for use as stated in the FDA summary.

More from William Cook Europe Aps

46 FDA decisions under this applicant name. See the company

  • P180001/S018Zenith Dissection Endovascular System (ZDEG/ZDES)William Cook Europe Aps · 2026
  • P180001/S017Zenith Fenestrated AAA Endovascular GraftWilliam Cook Europe Aps · 2026
  • P180001/S016Zenith Dissection Endovascular SystemWilliam Cook Europe Aps · 2026
  • K251596Lunderquist Extra Stiff Wire GuideWilliam Cook Europe Aps · 2025
  • K251499Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova…William Cook Europe Aps · 2025

Recent decisions in DTK

The DTK category page

  • K242612Option ELITE Vena Cava Filter System (352506070E 352506100E)Argon Medical Devices, Inc. · 2024
  • K240578VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter SystemB.Braun Medical, Inc. · 2024
  • K241507ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)Aln S.A.R.L. · 2024
  • K240257Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery KitBd · 2024
  • K211875Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filte…William Cook Europe Aps · 20211 recall

https://510kreport.com/device/K233680 · printed Nov 5, 2026

Cite this page

510(k) Report. “K233680: Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP); Günther Tulip Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-TULIP); Günther Tulip Vena Cava Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233680

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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