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. Device class: 2.
Clearance details
- Applicant
- Althin Medical AB an Affiliate of Baxter Intl
- Product code
- Code FJI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami Lakes, FL, US
Recent devices under product code FJI
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- K970679 — ALTRA FLUX 200 HEMODIALYZER
- K970681 — ALTRA NOVA 200 HEMODIALYZER
- K970446 — DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM
- K964922 — DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DELIVERY SYSTEM
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.