FRESENIUS ART HEMOADSORPTION SYSTEM— 510(k) K050273
Substantially EquivalentFresenius Medical Care North America
FDA 510(k) clearance K050273 for FRESENIUS ART HEMOADSORPTION SYSTEM, Substantially Equivalent on 2005-06-08. Applicant: Fresenius Medical Care North America. Device class: Unclassified.
Clearance details
- Applicant
- Fresenius Medical Care North America
- Product code
- Code LKN
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lexington, MA, US
Recent devices under product code LKN
view all- K192150 — AMICUS Separator System
- K183081 — Spectra Optia Apheresis System
- K180615 — AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter
- K181049 — Spectra Optia Apheresis System
- K172590 — Spectra Optia Apheresis System
More clearances from Fresenius Medical Care North America
view allAdverse events under product code LKN
product code LKN- Death
- 50
- Injury
- 314
- Total
- 364
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.