DeviceClearance

K010034

Substantially Equivalent

DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS-

Applicant
Cook, Inc.
Product code
FOZ
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Bloomington, IN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FOZ

product code FOZ
Death
38
Injury
2,290
Malfunction
25,858
Other
11
Total
28,197

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.