MCA(TM) 130 HEMODIALYZER— 510(k) K945623
Substantially EquivalentAlthin Medical AB an Affiliate of Baxter Intl
FDA 510(k) clearance K945623 for MCA(TM) 130 HEMODIALYZER, Substantially Equivalent on 1995-05-18. Applicant: Althin Medical AB an Affiliate of Baxter Intl.
Clearance details
- Applicant
- Althin Medical AB an Affiliate of Baxter Intl
- Product code
- Code FJI
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami Lakes, FL, US
Adverse events under product code FJI
product code FJI- 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.