RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014— 510(k) K991170

Clearance details

Applicant

Edwards Lifesciences Research Medical

Product code

Code DWF

Device class

Class 2

Regulation

21 CFR 870.4210

Advisory panel

Cardiovascular

Date received

1999-04-07

Decision date

1999-07-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Midvale, UT, US

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• K983791 — PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA1999-06-11
• K974259 — VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE1998-12-01

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 →