RESUBMITTED MICRON TRANSFUSION FILTER— 510(k) K873873

Substantially Equivalent

Travenol Laboratories, S.A.

FDA 510(k) clearance K873873 for RESUBMITTED MICRON TRANSFUSION FILTER, Substantially Equivalent on 1987-10-22. Applicant: Travenol Laboratories, S.A.. Device class: 2.

Clearance details

Applicant
Travenol Laboratories, S.A.
Product code
Code CAK
Device class
Class 2
Regulation
21 CFR 880.5440
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Round Lake, IL, US
Download summary PDFView on FDA.gov ↗

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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.