Cleared Special

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

K241248 · Spectrum Medical S.R.L. · Cardiovascular

May 2024

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K241248 is an FDA 510(k) clearance for the Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1), a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II — Special Controls, product code DWF), submitted by Spectrum Medical S.R.L. (Mirandola, IT). The FDA issued a Cleared decision on May 31, 2024, 28 days after receiving the submission on May 3, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.

Submission Details

510(k) Number	K241248 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 03, 2024
Decision Date	May 31, 2024
Days to Decision	28 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.4210