FDA Device Intelligence
HomeDevice types › DQO

Catheter, Intravascular, Diagnostic

FDA product code DQO · Class 2 · Cardiovascular

9,383
Registered devices
20,128
Adverse events
284
Recalls
501
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-04-02Cook IncorporatedMarker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with
2026-04-02Cook IncorporatedMarker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with
2026-04-02Cook IncorporatedMarker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with
2026-03-23Gentuity, LLCThe potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx P
2026-03-05Cook IncorporatedProducts from the affected device lots were labeled with expiration dates that exceed the true shelf life.
2026-03-03Angiodynamics, Inc.The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the cath
2026-03-03Angiodynamics, Inc.The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the cath
2026-03-03Angiodynamics, Inc.The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the cath
2026-03-03Angiodynamics, Inc.The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the cath
2026-03-03Angiodynamics, Inc.The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the cath

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