EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE— 510(k) K120780

Name: FDA 510(k) clearance K120780
Creator: U.S. Food and Drug Administration
Published: 2012-06-27

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K120780 for EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE, Substantially Equivalent on 2012-06-27. Applicant: Edwards Lifesciences, LLC. Device class: 2.

Clearance details

Applicant: Edwards Lifesciences, LLC
Product code: Code DWF
Device class: Class 2
Regulation: 21 CFR 870.4210
Advisory panel: Cardiovascular
Date received: 2012-03-14
Decision date: 2012-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Draper, UT, 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 K120780

K-number listed on FDA's recall record

Z-1322-2013 — Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9. Product Usage: The catheter introducer sheath kit provides access to the central venous circulation to facilitate catheter and guidewire insertion. The Proplege coronary sinus catheter provides retrograde cardioplegia during cardiopulmonary by-pass surgery.Class II·Terminated·Edwards Lifesciences, LLC·20130125

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120780.

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