FDA Device Intelligence
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Filter, Intravascular, Cardiovascular

FDA product code DTK · Class 2 · Cardiovascular

65
Registered devices
38,318
Adverse events
22
Recalls
83
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2025-09-12Argon Medical Devices, IncDue to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue could potential result in procedural delays and/o
2023-06-08Argon Medical Devices, IncThere is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism.
2022-02-14Cook Medical IncorporatedIFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events
2022-02-14Cook Medical IncorporatedIFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events
2019-02-25Cook Medical IncorporatedUpdates to the Instructions for Use.
2019-02-25Cook Medical IncorporatedUpdates to the Instructions for Use.
2019-02-25Cook Medical IncorporatedUpdates to the Instructions for Use.
2019-02-25Cook Medical IncorporatedUpdates to the Instructions for Use.
2019-02-25Cook Medical IncorporatedUpdates to the Instructions for Use.
2019-02-25Cook Medical IncorporatedUpdates to the Instructions for Use.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.