ASAHI HOLLOW FIBER KIDNEYS, AM-SERIES— 510(k) K830231
Substantially EquivalentAdvocacy International, Ltd.
FDA 510(k) clearance K830231 for ASAHI HOLLOW FIBER KIDNEYS, AM-SERIES, Substantially Equivalent on 1983-03-17. Applicant: Advocacy International, Ltd..
Clearance details
- Applicant
- Advocacy International, Ltd.
- Product code
- Code KOC
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code KOC
product code KOC- Death
- 4
- Total
- 4
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.