Bio-Medicus Adult Cannulae Kit— 510(k) K180456

Clearance details

Applicant

Medtronic, Inc.

Product code

Code DWF

Device class

Class 2

Regulation

21 CFR 870.4210

Advisory panel

Cardiovascular

Date received

2018-02-20

Decision date

2018-03-22

Decision

Substantially Equivalent

Clearance type

Special

Location

Mounds View, 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-2738-2026 — Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannulaClass II·Ongoing·Medtronic Perfusion Systems·20260525

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K180456.