FDA 510(k) Clearance for Devon Medical’s extriCARE® 3600 High-Flow NPWT System

The U.S. FDA has granted 510(k) clearance for Devon Medical Products to market its extriCARE® 3600 Negative Pressure Wound Therapy (NPWT) pump and foam dressing kit.

Background

Devon Medical Products, Inc. is an ISO 13485 medical device manufacturer, designer, and distributor with a catalogue of products that it says are innovative, high-quality and affordable for healthcare markets and patients worldwide.

The newly cleared extriCARE® 3600 NPWT pump and foam kit are intended for use on wounds with large amounts of exudate, including wounds of critical nature. The products were designed for use in acute care and post-acute care settings, as well as skilled nursing facilities. Features of the extriCARE® 3600 include a 24-hour continuous, rechargeable battery, a rotatable back-mount for securing the device to hospital bed rails and IV poles, simple pressure settings between 40-200mmHg of pressure, and various alarms signaling air leakage, low battery, and other errors. The device currently utilizes a 400cc disposable canister, and a 1,000cc canister is in development.

Devon Medical Products is showcasing the extriCARE® 3600 pump and foam dressing kits at the 46th Annual Wound, Ostomy and Continence Nurses Society™ Conference in Nashville, Tennessee this week.

Company comments

“This regulatory approval is a significant step for Devon Medical Products as it opens the door for us to treat a broader range of wounds commonly found in institutional settings,” says Chip Ross, president of Devon Medical Products. “We added this larger NPWT pump and a foam wound dressing kit to help complete our NPWT product line and provide wound care professionals with the technology they need to manage all types of wounds. We are proud to now offer a complete line of NPWT pumps, dressings, and accessories at a fraction of the cost of many of our competitors.”

Source: Devon Medical Products, Inc., Business Wire

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