DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT— 510(k) K120988

Name: FDA 510(k) clearance K120988
Creator: U.S. Food and Drug Administration
Published: 2012-07-25

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K120988 for DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT, Substantially Equivalent on 2012-07-25. Applicant: Medtronic, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic, Inc.
Product code: Code DWF
Device class: Class 2
Regulation: 21 CFR 870.4210
Advisory panel: Cardiovascular
Date received: 2012-04-02
Decision date: 2012-07-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DWF

product code DWF

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 →

Recalls naming K120988

K-number listed on FDA's recall record

Z-3128-2024 — Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312Class II·Ongoing·Medtronic Perfusion Systems·20240709
Z-0908-2013 — Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass procedures. Model numbers: 67312; 67314; CB67314; 67316; 67318; CB67318; 67320; 69312; 69314; 69316; 69318; 69320; 69322; 69324; 69328; 69331.Class II·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·20130219

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120988.

Data sourced from openFDA. This site is unofficial and independent of the FDA.