CASCADE HEMODIALYSIS/APHERESIS CATHETER— 510(k) K130851

Unknown

Health Line International Corporation

FDA 510(k) clearance K130851 for CASCADE HEMODIALYSIS/APHERESIS CATHETER, Unknown on 2014-01-09. Applicant: Health Line International Corporation.

Clearance details

Applicant
Health Line International Corporation
Product code
Code MSD
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Unknown
Clearance type
Traditional
Location
Centerville, UT, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code MSD

product code MSD
Death
67
Injury
545
Malfunction
3,661
Total
4,273

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.