K202224
Substantially EquivalentSpaceOAR System
- Applicant
- Boston Scientific Corporation
- Product code
- OVB
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Marlboro, MA, US
Adverse events under product code OVB
product code OVB- Death
- 7
- Injury
- 658
- Malfunction
- 1,206
- Total
- 1,871
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.