DeviceClearance

K152938

Substantially Equivalent

DBB-06 Hemodialysis Delivery System

Applicant
NIKKISO CO., LTD.
Product code
KDI
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Shibuya-Ku, JP
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.