A.V. FISTULA NEEDLE— 510(k) K001496
Substantially EquivalentExelint International, Co.
FDA 510(k) clearance K001496 for A.V. FISTULA NEEDLE, Substantially Equivalent on 2000-08-01. Applicant: Exelint International, Co..
Clearance details
- Applicant
- Exelint International, Co.
- Product code
- Code FIE
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Angeles, CA, US
Adverse events under product code FIE
product code FIE- 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.