MCA(TM) 180 HEMODIALYZER— 510(k) K945622
Substantially EquivalentAlthin Medical AB an Affiliate of Baxter Intl
FDA 510(k) clearance K945622 for MCA(TM) 180 HEMODIALYZER, Substantially Equivalent on 1995-05-25. 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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- 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.