Flowguard Catheters & Cannalae

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

510(k) Number

K813037 ↗

FDA Product Code

DWF

Device Class

Class II

Regulation

21 CFR Part 870.4210

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Asahi Hollow Fiber Kidneys Nr Series

  Class II

  FDA 510(k) K830183 Active Cleared 17 Mar 1983

• Toyo Jozo G-Gtp Test

  Class I

  FDA 510(k) K842104 Active Cleared 10 Aug 1984

• Lipase UV [Toyo]

  Class I

  FDA 510(k) K874027 Active Cleared 27 May 1988

• Toyo Jozo Uric Acid Test

  Class I

  FDA 510(k) K842103 Active Cleared 12 Aug 1984

• Eiken Kizai Artificial Kidney Blood Cir

  Class II

  FDA 510(k) K823733 Active Cleared 14 Jan 1983

• Asahi Hollow Fiber Kidneys, Am-Series

  Class II

  FDA 510(k) K830231 Active Cleared 17 Mar 1983

See all devices from Advocacy International, Ltd. →

• Are the Flowguard Catheters & Cannulae reusable or designed for single-use only?

  The Flowguard Catheters & Cannulae are explicitly designed for single-use only. This is stated in the device description, which emphasizes their use as sterile medical instruments intended for controlled clinical settings like operating rooms or cardiac catheterization labs. Reuse is not recommended or supported by the manufacturer.

• What types of procedures are these catheters and cannulae primarily intended for?

  These devices are specifically designed for cardiopulmonary bypass procedures, such as open-heart surgeries. Their construction ensures controlled fluid flow within the cardiovascular system while minimizing vascular trauma. They are not intended for general vascular access or non-cardiac applications.

• How are the Flowguard Catheters & Cannulae supplied, and what does sterility mean for clinical use?

  They are supplied as sterile, single-use devices, ready for immediate clinical use in controlled environments like operating rooms or cardiac catheterization labs. Sterility ensures they meet regulatory standards for infection control, making them safe for direct patient use without additional sterilization steps.

• What does the regulatory route for this device entail, and how long has it been cleared?

  The Flowguard Catheters & Cannulae were granted FDA 510(k) clearance in 1981 under the traditional review process, with a decision code of SESE (Substantially Equivalent). They fall under the Class II device classification and are associated with the Cardiovascular (CV) advisory committee. The clearance was filed on October 28, 1981, and finalized on December 14, 1981.

• Do these catheters and cannulae come in multiple sizes, and how are they differentiated?

  Yes, the product line includes multiple sizes and configurations, each referenced by unique FEI numbers (e.g., 3009211636, 3010017366). These variations accommodate different patient needs and procedural requirements, ensuring compatibility with various clinical scenarios during cardiopulmonary bypass.