DeviceClearance

K081313

Substantially Equivalent

SH14 HEMOCONCENTRATOR

Applicant
Sorin Group Italia S.R.L.
Product code
KDI
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Waltham, MA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code KDI

product code KDI
Death
352
Injury
1,474
Malfunction
12,534
Other
4
Total
14,364

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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