COATRON F(SAME AS COATRON, BUT ALSO DOES FIBRINOGE— 510(k) K851153
Substantially EquivalentAstral Medical Systems
FDA 510(k) clearance K851153 for COATRON F(SAME AS COATRON, BUT ALSO DOES FIBRINOGE, Substantially Equivalent on 1985-11-05. Applicant: Astral Medical Systems.
Clearance details
- Applicant
- Astral Medical Systems
- Product code
- Code JPA
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Buena Park, CA, US
Adverse events under product code JPA
product code JPA- Death
- 6
- Total
- 6
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.