Confirm Rx Insertable Cardiac Monitor— 510(k) K202888
Substantially EquivalentAbbott (St. Jude Medical)
FDA 510(k) clearance K202888 for Confirm Rx Insertable Cardiac Monitor, Substantially Equivalent on 2020-11-23. Applicant: Abbott (St. Jude Medical).
Clearance details
- Applicant
- Abbott (St. Jude Medical)
- Product code
- Code MXC
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sylmar, CA, US
Adverse events under product code MXC
product code MXC- Death
- 4
- Injury
- 758
- Malfunction
- 5,066
- Total
- 5,828
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.