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Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)

by Spectrum Medical S.R.L.

510(k) K241248

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK241248 Date31 May 2024ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
DWF
Device Class
Class II
Regulation
21 CFR Part 870.4210
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) is a vascular catheter, cannula and tubing classified for cardiopulmonary bypass. It provides two lumens within a single 31F cannula to enable simultaneous venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal procedures.

The device is supplied as a sterile, single‑use cannula intended for up to six hours of extracorporeal life support with a single‑site insertion that reduces procedural invasiveness. It carries FDA 510(k) clearance (decision code SESE) as a Class II device and is identified by K‑number K241248 and product code DWF.

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