MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L AND 11014L— 510(k) K100274

Clearance details

Applicant

Medtronic, Inc.

Product code

Code DWF

Device class

Class 2

Regulation

21 CFR 870.4210

Advisory panel

Cardiovascular

Date received

2010-01-29

Decision date

2010-05-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Minneapolis, MN, 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

• K262735 — LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)2026-08-28
• K262005 — Affera Integrated Mapping System2026-08-21
• K261335 — VitalFlow Set with Balance Biosurface2026-07-31
• K261866 — Concerto Versa Detachable Coil2026-06-24
• K253998 — Clearview Intracoronary Shunts2026-01-20

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-1306-2025 — Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD 14GA, model no. 11014 2. MiAR Cannula: A. CANNULA 11012L AR FLOWGUARD LONG 12GA, model no 11012L B. CANNULA 11014L AR FLOWGUARD 14FR LONG, model no. 11014L 3. DLP Aortic Root Cannula with Vent Line A. CANNULA 21012 AR VENT FLOW 12GA, model no. 21012 B. CANNULA 21014 AR VENT FLOW 14GA, model no. 21014Class I·Ongoing·Medtronic Perfusion Systems·20250205

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K100274.