NEOCARE 20 MICRON BLOOD FILTER— 510(k) K000719

Substantially Equivalent

Whatman, Inc.

FDA 510(k) clearance K000719 for NEOCARE 20 MICRON BLOOD FILTER, Substantially Equivalent on 2000-05-30. Applicant: Whatman, Inc..

Clearance details

Applicant
Whatman, Inc.
Product code
Code CAK
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ann Arbor, MI, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code CAK

product code CAK
Malfunction
476
Total
476

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.