Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set— 510(k) K213540

Clearance details

Applicant

Qura S.R.L

Product code

Code DWF

Device class

Class 2

Regulation

21 CFR 870.4210

Advisory panel

Cardiovascular

Date received

2021-11-08

Decision date

2022-05-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mirandola, IT

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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 →