Cleared Traditional

ProtekDuo Veno-Venous Cannula Sets

K232480 · Cardiacassist, Inc. · Cardiovascular

Oct 2023

Decision

51d

Days

Class 2

Risk

About This 510(k) Submission

K232480 is an FDA 510(k) clearance for the ProtekDuo Veno-Venous Cannula Sets, a Dual Lumen Ecmo Cannula (Class II — Special Controls, product code PZS), submitted by Cardiacassist, Inc. (Pittsburg, US). The FDA issued a Cleared decision on October 6, 2023, 51 days after receiving the submission on August 16, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4100.

Submission Details

510(k) Number	K232480 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 16, 2023
Decision Date	October 06, 2023
Days to Decision	51 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	PZS — Dual Lumen Ecmo Cannula
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.4100
Definition	Long Term Support Greater Than 6 Hours For Acute Respiratory Or Acute Cardiopulmonary Failure, Where Other Available Treatment Options Have Failed, And Continued Clinical Deterioration Is Expected Or The Risk Of Death Is Imminent.