SELECT 3D ARTERIAL CANNULA— 510(k) K043179

Clearance details

Applicant

Medtronic Perfusion Systems

Product code

Code DWF

Device class

Class 2

Regulation

21 CFR 870.4210

Advisory panel

Cardiovascular

Date received

2004-11-17

Decision date

2005-02-08

Decision

Substantially Equivalent

Clearance type

Special

Location

Minneapolis, MN, US

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• K123351 — AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE2013-03-19
• K101186 — AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG2010-09-03
• K090869 — MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TD2009-08-27

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-0995-2014 — Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20 Fr.). Non-Vented Cannulae, models 78718 (18 Fr.) and 78720 (20 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Select 3D Arterial Cannulae both have clear flexible, thin wall wire-wound PVC bodies with angled, beveled tips. The proximal end of the cannula includes a 3/8" (0.95 cm) vented or non-vented connector with a peel cap. The vented connector allows air to be vented from the cannula before connection to the perfusion line. The Select 3D Arterial Cannula tip has three integrated flutes which help diffuse and disperse blood flow. The cannula body features a tip orientation line indicating direction of the cannula tip during cannulation. Overall cannula length is 11.5" (29.2 cm). These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.Class II·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·20140130

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K043179.