PEDIATRIC ARTERIAL CANNULA— 510(k) K023251

Clearance details

Applicant

Polystan A/S

Product code

Code DWF

Device class

Class 2

Regulation

21 CFR 870.4210

Advisory panel

Cardiovascular

Date received

2002-09-30

Decision date

2002-12-04

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Vaerlose, DK

• 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

• K013038 — SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 0160102002-08-14
• K022281 — SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 0160452002-08-06
• K980974 — SAFE MINI2000-10-13
• K953976 — SAFE MICRO1997-02-04
• K912082 — SAFE II1991-12-04

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-2210-2012 — Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe 31 76437 Rastatt Germany Phone +49 7222 932-0 Fax: +49 7222 932-1888 info.cp@maquet.com www.maquet.com Used to introduce blood and sterile solution to the circulation system during extracorporeal circulation proceduresClass II·Terminated·Maquet Inc.·20120529

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K023251.