ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE— 510(k) K043249
Substantially EquivalentAtrion Medical Products, Inc.
FDA 510(k) clearance K043249 for ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE, Substantially Equivalent on 2005-05-25. Applicant: Atrion Medical Products, Inc..
Clearance details
- Applicant
- Atrion Medical Products, Inc.
- Product code
- Code FMI
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Arab, AL, US
Adverse events under product code FMI
product code FMI- Death
- 28
- Injury
- 1,517
- Malfunction
- 23,981
- Other
- 18
- Total
- 25,544
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.