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Duraflo II Heparin Treated Suction Wands Var. Mod.

by Baxter Bentley Laboratories, Inc.

510(k) K905311

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK905311 Date15 Jan 1991ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DWD
Device Class
Class II
Regulation
21 CFR Part 870.4430
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Duraflo II Heparin Treated Suction Wands Variable Modification is an intracardiac suction control device designed for use during cardiopulmonary bypass procedures. It is classified as a Class II medical device under 21 CFR 870.4430 and is intended for controlled aspiration of fluids within the cardiovascular system, reducing the risk of clotting and improving surgical efficiency.

These suction wands are heparin-treated to minimize clotting during use and are supplied as a reusable device. They are intended for use in sterile operating room environments and must comply with MRI safety standards as applicable. The variable modification allows for adaptability to different surgical requirements, and the device is authorized under FDA 510(k) clearance K905311, with a decision date of January 15, 1991.

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