CHANGE TO CATHODE POWDER SPECIFICATION— 510(k) K881904
Substantially EquivalentTelectronics and Cordis Pacing Systems
FDA 510(k) clearance K881904 for CHANGE TO CATHODE POWDER SPECIFICATION, Substantially Equivalent on 1988-07-22. Applicant: Telectronics and Cordis Pacing Systems.
Clearance details
- Applicant
- Telectronics and Cordis Pacing Systems
- Product code
- Code DXY
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, 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.