SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER— 510(k) K896203
Substantially EquivalentSolco Basle, Inc.
FDA 510(k) clearance K896203 for SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER, Substantially Equivalent on 1990-02-01. Applicant: Solco Basle, Inc.. Device class: 2.
Clearance details
- Applicant
- Solco Basle, Inc.
- 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
- Hingham, MA, US
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More clearances from Solco Basle, Inc.
view allAdverse 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.