PROTEK Duo 31 Fr. Veno-Venous Cannula Set— 510(k) K160257

Clearance details

Applicant

Cardiacassist, Inc.

Product code

Code DWF

Device class

Class 2

Regulation

21 CFR 870.4210

Advisory panel

Cardiovascular

Date received

2016-02-01

Decision date

2016-03-04

Decision

Substantially Equivalent

Clearance type

Special

Location

Pittsburgh, PA, US

• K260195 — Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae2026-04-23
• K250937 — Venous Return Cannulae2026-03-11
• K260043 — Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)2026-02-23
• K253203 — Retrograde Coronary Sinus Perfusion Cannulae2026-02-19
• K253671 — Dual Stage Venous Cannulae2026-01-30

• K233736 — LifeSPARC System2024-01-19
• K232480 — ProtekDuo Veno-Venous Cannula Sets2023-10-06
• K232132 — LifeSPARC System2023-08-03
• K211830 — LifeSPARC System2022-11-15
• K202751 — TandemHeart Pump and Escort Controller2021-03-26

Death

106

Injury

386

Malfunction

2,323

Total

2,815

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0311-2022 — SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components: a) 31 Fr ProtekDuo Veno-Venous Cannula Set b) LifeSPARC Pump c) 14Fr to 26 Fr Dilator Set d) TandemHeart Wrap. Kit Number: 5820-3118 Intended use is applicable to the intended use of specific devices included in the kit.Class III·Ongoing·Cardiac Assist, Inc·20211014

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160257.