Bio-Medicus Adult Cannulae and Introducer— 510(k) K142673

Clearance details

Applicant

Medtronic, Inc.

Product code

Code DWF

Device class

Class 2

Regulation

21 CFR 870.4210

Advisory panel

Cardiovascular

Date received

2014-09-19

Decision date

2014-11-18

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mounds View, MN, US

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• 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 →