ProtekDuo Veno-Venous Cannula Sets

Q: What is the product code of K232480?

The FDA product code is PZS – Dual Lumen Ecmo Cannula, a Class II (moderate risk) device regulated under 21 CFR 870.4100.

FDA 510(k) K232480 · Cardiacassist, Inc.

Substantially Equivalent

510(k) numberK232480

Submission

Device name: ProtekDuo Veno-Venous Cannula Sets
Applicant: Cardiacassist, Inc.
Pittsburg, PA, US
Received: August 16, 2023
Decision date: October 6, 2023
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: PZS – Dual Lumen Ecmo Cannula
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.4100
Specialty: Cardiovascular

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.

Other 510(k)s with product code PZS

510(k)	Device	Applicant	Decision
K203409	MC3 Crescent Jugular Dual Lumen CatheterPZS · Traditional	Mc3, Inc.	05/03/2021SE
K180151	MC3 Jugular Dual Lumen CatheterPZS · Traditional	Mc3 Incorporated	07/16/2018SE
K171610	MC3 QuickFlow Dual Lumen CatheterPZS · Traditional	Mc3 Incorporated	11/16/2017SE

More from Mc3 Incorporated

510(k)	Device	Decision
K233736	LifeSPARC SystemQNR · Traditional	01/19/2024SE
K232132	LifeSPARC SystemKFM · Special	08/03/2023SE
K211830	LifeSPARC SystemQNR · Traditional	11/15/2022SE
K202751	TandemHeart Pump and Escort ControllerQNR · Traditional	03/26/2021SE
K183623	LifeSPARC Pump, LifeSPARC ControllerKFM · Traditional	07/09/2019SE
K181150	ProtekDuo Mini Veno-Venous Cannula SetDWF · Special	05/25/2018SE
K162181	Protek Duo Venous Dilator Set, Protek Solo Venous Dilator SetDRE · Traditional	01/06/2017SE
K162214	Protek Solo 24 Fr Venous Cannula SetDWF · Traditional	11/30/2016SE
K160257	PROTEK Duo 31 Fr. Veno-Venous Cannula SetDWF · Special	03/04/2016SE
K153295	TandemLung OxygenatorDTZ · Traditional	02/26/2016SE

Questions and answers

When was ProtekDuo Veno-Venous Cannula Sets cleared by the FDA?

ProtekDuo Veno-Venous Cannula Sets (K232480) received a 510(k) decision of Substantially Equivalent on October 6, 2023, 51 days after the submission was received.

What is the product code of K232480?

The FDA product code is PZS – Dual Lumen Ecmo Cannula, a Class II (moderate risk) device regulated under 21 CFR 870.4100.