SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM— 510(k) K851365
Substantially EquivalentSorin Biomedica, Fiat, USA, Inc.
FDA 510(k) clearance K851365 for SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM, Substantially Equivalent on 1985-12-03. Applicant: Sorin Biomedica, Fiat, USA, Inc..
Clearance details
- Applicant
- Sorin Biomedica, Fiat, USA, Inc.
- Product code
- Code DXY
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
Adverse events under product code DXY
product code DXY- Death
- 240
- Injury
- 2,328
- Malfunction
- 2,096
- Total
- 4,664
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.