ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS— 510(k) K962309
Substantially EquivalentAlthin Medical AB an Affiliate of Baxter Intl
FDA 510(k) clearance K962309 for ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS, Substantially Equivalent on 1996-12-27. 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.