CRITIKON I.V. FILTER— 510(k) K842075
Substantially EquivalentCritikon Company, LLC
FDA 510(k) clearance K842075 for CRITIKON I.V. FILTER, Substantially Equivalent on 1984-06-28. Applicant: Critikon Company, LLC.
Clearance details
- Applicant
- Critikon Company, LLC
- Product code
- Code FPB
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code FPB
product code FPB- Other
- 1
- Total
- 1
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.