FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72— 510(k) K982822
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K982822 for FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72, Substantially Equivalent on 1998-09-30. Applicant: Baxter Healthcare Corp. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corp
- 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
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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.