SPECTRA OPTIA APHERESIS SYSTEM— 510(k) K113480
Substantially EquivalentCaridianbct, Inc..
FDA 510(k) clearance K113480 for SPECTRA OPTIA APHERESIS SYSTEM, Substantially Equivalent on 2012-01-20. Applicant: Caridianbct, Inc... Device class: Unclassified.
Clearance details
- Applicant
- Caridianbct, Inc..
- Product code
- Code LKN
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Lakewood, CO, 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 Caridianbct, Inc..
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.