Bio-Medicus Pediatric Cannula and Introducers— 510(k) K143083

Clearance details

Applicant

Medtronic, Inc.

Product code

Code DWF

Device class

Class 2

Regulation

21 CFR 870.4210

Advisory panel

Cardiovascular

Date received

2014-10-27

Decision date

2015-03-25

Decision

Substantially Equivalent

Clearance type

Traditional

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-0640-2018 — GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric positioning system is indicated for use in gastric and bariatric surgical procedures for the application of suction, decompression and to radially expand the stomach, to drain gastric fluids, to test for leaks, to provide visible and tactile delineation of the lesser curvature of the stomach and to serve as a sizing guide for gastric and bariatric procedures, such as sleeve gastrectomy.Class II·Terminated·Covidien LLC·20170921

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143083.