SARNS VISIFLOW AORTIC ARCH CANNULA— 510(k) K874896

Clearance details

Applicant

3M Health Care, Sarns

Product code

Code DWF

Device class

Class 2

Regulation

21 CFR 870.4210

Advisory panel

Cardiovascular

Date received

1987-12-01

Decision date

1988-02-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Ann Arbor, MI, US

• K260195 — Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae2026-04-23
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• K253203 — Retrograde Coronary Sinus Perfusion Cannulae2026-02-19
• K253671 — Dual Stage Venous Cannulae2026-01-30

• K960916 — SAMS 8000 CARDIOPLEGIA MONITOR1996-06-04
• K953901 — SARNS 800 ROLLER PUMP1996-04-19
• K950739 — 3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM1995-11-17
• K941653 — SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION1994-08-24
• K941654 — SARNS FILTERED VENOUS RESERVIOR MODIFICATION1994-07-26

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-2094-2014 — Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with or without side holes and/or luer Product Usage: The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.Class II·Terminated·Terumo Cardiovascular Systems Corporation·20140523

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K874896.