CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING— 510(k) K002238
Substantially EquivalentTerumo Cardiovascular Systems Corp.
FDA 510(k) clearance K002238 for CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING, Substantially Equivalent on 2000-08-22. Applicant: Terumo Cardiovascular Systems Corp..
Clearance details
- Applicant
- Terumo Cardiovascular Systems Corp.
- Product code
- Code DTN
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Elkton, MD, US
Adverse events under product code DTN
product code DTN- Death
- 3
- Total
- 3
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.