FILTER, TRANSFUSION BLOOD, INTERSEPT— 510(k) K760222
Substantially EquivalentSurgikos, Inc.
FDA 510(k) clearance K760222 for FILTER, TRANSFUSION BLOOD, INTERSEPT, Substantially Equivalent on 1976-08-06. Applicant: Surgikos, Inc..
Clearance details
- Applicant
- Surgikos, Inc.
- Product code
- Code CAK
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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.