CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER— 510(k) K946188
Substantially Equivalent - Subject to Tracking Reg.Cardiac Control Systems, Inc.
FDA 510(k) clearance K946188 for CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER, Substantially Equivalent - Subject to Tracking Reg. on 1995-05-15. Applicant: Cardiac Control Systems, Inc..
Clearance details
- Applicant
- Cardiac Control Systems, Inc.
- Product code
- Code DXY
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Clearance type
- Traditional
- Location
- Palm Coast, 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.