EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET— 510(k) K003627
Substantially EquivalentExelint International, Co.
FDA 510(k) clearance K003627 for EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET, Substantially Equivalent on 2001-02-08. Applicant: Exelint International, Co..
Clearance details
- Applicant
- Exelint International, Co.
- Product code
- Code FMI
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Angeles, CA, 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.