Perfusion Catheter

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K872790 ↗

FDA Product Code

DQT

Device Class

Class II

Regulation

21 CFR Part 870.1370

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Leuco Prep

  Class I

  FDA 510(k) K854093 Active Cleared 12 Nov 1985

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  Class II

  FDA 510(k) K874427 Active Cleared 5 Jan 1988

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  Class I

  FDA 510(k) K915478 Active Cleared 27 Jan 1992

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  Class II

  FDA 510(k) K844645 Active Cleared 5 Mar 1985

• Holesterol Delta Test Assay

  Class I

  FDA 510(k) K771582 Active Cleared 13 Sep 1977

• Delta Test Triglycerides

  Class I

  FDA 510(k) K802136 Active Cleared 10 Oct 1980

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• What is the BD Perfusion Catheter used for?

  The BD Perfusion Catheter is designed to selectively block fluid flow through one or more lumens or orifices in a catheter. This allows clinicians to control perfusion during procedures like perfusion studies or selective catheterization, ensuring precise fluid management in cardiovascular diagnostics or interventional settings.

• Is the BD Perfusion Catheter single-use or reusable?

  The BD Perfusion Catheter is supplied as a single-use device. This design ensures sterility and reduces the risk of contamination or cross-infection, which is critical in clinical settings where controlled perfusion is required.

• How should the BD Perfusion Catheter be stored?

  The BD Perfusion Catheter must be stored according to sterile medical device protocols to maintain its integrity before use. Proper storage conditions prevent damage or compromise of sterility, ensuring the device remains safe and effective for its intended clinical application.

• What regulatory pathway does the BD Perfusion Catheter follow?

  The BD Perfusion Catheter is regulated under the FDA’s Traditional 510(k) pathway and holds a Class II designation. It received FDA clearance under the product code DQT, which pertains to controlled perfusion applications in the cardiovascular category.

• Can this catheter be used in non-cardiovascular procedures?

  The BD Perfusion Catheter is specifically intended for use in controlled perfusion applications within the cardiovascular field, such as perfusion studies or selective catheterization. While its design enables selective occlusion, its primary indication is tied to cardiovascular diagnostics or interventional procedures.