SMARTSITE STOPCOCK— 510(k) K071400
Substantially EquivalentCardinal Health, Alaris Products
FDA 510(k) clearance K071400 for SMARTSITE STOPCOCK, Substantially Equivalent on 2007-12-14. Applicant: Cardinal Health, Alaris Products.
Clearance details
- Applicant
- Cardinal Health, Alaris Products
- Product code
- Code FMG
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Adverse events under product code FMG
product code FMG- Death
- 14
- Malfunction
- 3,433
- Other
- 1
- Total
- 3,448
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.