Saphenous Vein Irrigation, Pressurizatio

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K790938 ↗

FDA Product Code

DWP

Device Class

Class II

Regulation

21 CFR Part 870.4475

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Stockert-Shiley Caps Venous Occlusion Clamp

  Class I

  FDA 510(k) K864890 Active Cleared 19 Feb 1987

• Basic Heater-Cooler Unit, 115/100V 16-02-20

  Class II

  FDA 510(k) K883330 Active Cleared 26 Sep 1988

• Schneider-Shiley Y-Connector with Rotator

  Class II

  FDA 510(k) K862464 Active Cleared 28 Aug 1986

• Expanded Use for Shiley 3l Cardiotomy Reservoir

  Class II

  FDA 510(k) K872721 Active Cleared 23 Sep 1987

• Shiley Venous Reservoir

  Class II

  FDA 510(k) K854841 Active Cleared 10 Feb 1986

• Arterial Embolectomy Catheter

  Class II

  FDA 510(k) K840198 Active Cleared 3 Aug 1984

See all devices from Shiley, Inc. →

• What is the primary purpose of the Saphenous Vein Irrigation, Pressurization device in surgical procedures?

  This device is designed specifically for irrigating and pressurizing the saphenous vein during cardiovascular surgical procedures. Its purpose is to deliver controlled irrigation fluids, which improves visibility of the vessel and helps minimize tissue trauma during preparation or anastomosis (surgical connection). This is particularly useful in delicate vascular surgeries where clear visualization and gentle handling are critical.

• Is this device intended for single-use or can it be reused after sterilization?

  The device is explicitly labeled as a single-use item and is supplied in a non-sterile state. Reuse is not recommended or supported by the manufacturer, as single-use medical devices are designed for one-time use to ensure patient safety and maintain sterility standards. Sterilization processes for reuse are not validated for this product.

• What types of surgical settings is this device intended for, and how is it classified by regulatory authorities?

  This device is intended exclusively for cardiovascular surgical settings, where saphenous vein preparation or anastomosis is performed. Regulatory classification places it under FDA 510(k) clearance (K790938) as a Class II – Special Controls device, governed by regulation 870.4475 and categorized under product code DWP (Dilator, Vessel, Surgical). The clearance was granted in 1979 and is based on a determination of substantial equivalence to a predicate device.

• How should this device be stored before use, and are there any special handling requirements?

  Since the device is non-sterile, it must be sterilized by the facility prior to use following standard surgical protocols. Storage should adhere to manufacturer guidelines for non-sterile medical devices, typically in a clean, dry environment protected from contamination. Always check the packaging for expiration dates or storage instructions, and ensure the device is handled with sterile techniques once prepared for surgery.