REVEAL INSERTABLE LOOP RECORDER (ILR) SYSTEM— 510(k) K972242
Substantially Equivalent - Subject to Tracking Reg.Medtronic Vascular
FDA 510(k) clearance K972242 for REVEAL INSERTABLE LOOP RECORDER (ILR) SYSTEM, Substantially Equivalent - Subject to Tracking Reg. on 1998-01-16. Applicant: Medtronic Vascular.
Clearance details
- Applicant
- Medtronic Vascular
- Product code
- Code MXC
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Clearance type
- Traditional
- Location
- Minneapolis, MN, 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.