Profuse Infusion System

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

510(k) Number

K912877 ↗

FDA Product Code

DQY

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• Lake Region Variable Stiffness Guidewire (Vsgw)

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See all devices from Lake Region Mfg., Inc. →

• What is the Profuse Infusion System used for?

  The Profuse Infusion System is designed specifically for controlled delivery of intravenous fluids during procedures involving venous stents. Its purpose is to provide regulated fluid administration, minimizing risks associated with variable or uncontrolled infusion rates in critical clinical environments.

• Is the Profuse Infusion System single-use or reusable?

  The Profuse Infusion System is supplied as a reusable device, intended for use in hospital or procedural settings where sterile conditions are maintained. Reusability allows for cost-effective deployment in clinical environments where multiple procedures may require precise fluid management.

• What regulatory pathway was followed for the Profuse Infusion System?

  The Profuse Infusion System received FDA clearance through a 510(k) submission (K912877), classified as substantially equivalent to a predicate device. The review was conducted by the FDA’s Cardiovascular (CV) Advisory Committee in 1991, confirming its compliance with regulatory standards for Class 2 medical devices.

• Does the Profuse Infusion System have size or model variations?

  The available documentation does not specify size variations or distinct model references for the Profuse Infusion System. It is described as a single system designed for controlled fluid delivery in venous stent procedures, with no additional variants noted.

• How should the Profuse Infusion System be stored?

  Since the Profuse Infusion System is reusable and intended for use in sterile clinical environments, storage should follow standard protocols for reusable medical devices. This includes cleaning, disinfection, and proper maintenance between uses to ensure reliability and sterility for subsequent procedures.