EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2— 510(k) K082279
Substantially EquivalentSt Jude Medical
FDA 510(k) clearance K082279 for EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2, Substantially Equivalent on 2008-09-16. Applicant: St Jude Medical.
Clearance details
- Applicant
- St Jude Medical
- Product code
- Code OCL
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Sunnyvale, CA, US
Adverse events under product code OCL
product code OCL- Death
- 34
- Injury
- 256
- Total
- 290
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.