510(k) K952364— OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)
Substantially Equivalent - Subject to Tracking Reg.Ela Medical, Inc.
Clearance details
- Applicant
- Ela Medical, Inc.
- Product code
- Code DXY
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Clearance type
- Traditional
- Location
- Minnetonka, MN, 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.