VOYAGER 12— 510(k) K062469
Substantially EquivalentDel Mar Reynolds Medical, Ltd.
FDA 510(k) clearance K062469 for VOYAGER 12, Substantially Equivalent on 2006-11-03. Applicant: Del Mar Reynolds Medical, Ltd..
Clearance details
- Applicant
- Del Mar Reynolds Medical, Ltd.
- Product code
- Code DPS
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hasbrouck Heights, NJ, US
Adverse events under product code DPS
product code DPS- Death
- 7
- Total
- 7
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.