Vascutek Vascular Prostheses, Extra Soft/Low Woven

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

510(k) Number

K861808 ↗

FDA Product Code

DSY

Device Class

Class II

Regulation

21 CFR Part 870.3450

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Cobe Laboratories, Inc. →

• What types of vascular procedures is this prosthesis designed to assist with, and what makes it suitable for those uses?

  The Vascutek Vascular Prostheses, Extra Soft/Low Woven is specifically designed for repairing, replacing, or bypassing sections of native or artificial blood vessels—excluding coronary or cerebral vessels. Its construction emphasizes flexibility and durability, making it ideal for vascular reconstruction procedures where a graft must conform to the body’s movement while maintaining structural integrity over time.

• How many sizes are available for this vascular prosthesis, and how are they identified?

  This device comes in multiple sizes, each identified by a unique FEI (Firm’s Establishment Identifier) number. The available sizes include: 1721676, 1018233, 3002707083, 3002807041, 3010407203, 1220948, 3013718163, 3010097171, 3003094851, 3015309643, 2020394, 2017233, 2242352, 3002808437, 3012536737, 1220477, 2246552, 3006082230, 3033589330, 1720929, 3011175548, 3015225571, 1000517719, 1721504, 3007676031, and 3006950086. These FEI numbers correspond to specific diameters and lengths tailored for different clinical needs.

• Is this prosthesis intended for single-use only, and what storage requirements apply?

  Yes, the Vascutek Vascular Prostheses is supplied as a sterile, single-use device. To maintain sterility and integrity before use, it must be stored and handled according to standard sterile medical device protocols. This includes keeping it in its original packaging, away from contamination, and following manufacturer guidelines for shelf life.

• What regulatory pathway was followed for this device’s clearance, and which committee was involved?

  The Vascutek Vascular Prostheses, Extra Soft/Low Woven underwent a traditional 510(k) clearance process through the FDA, classified under Class II. The review was conducted by the Cardiovascular (CV) Advisory Committee, reflecting its intended use in vascular reconstruction procedures. The clearance number is K861808, issued on September 15, 1986.