LUTZ NEEDLE— 510(k) K013892
Substantially EquivalentBallard Medical Products
FDA 510(k) clearance K013892 for LUTZ NEEDLE, Substantially Equivalent on 2002-07-11. Applicant: Ballard Medical Products.
Clearance details
- Applicant
- Ballard Medical Products
- Product code
- Code BSP
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Draper, UT, US
Adverse events under product code BSP
product code BSP- Death
- 2
- Total
- 2
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.