SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200— 510(k) K071079
Substantially EquivalentGambro Bct, Inc.
FDA 510(k) clearance K071079 for SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200, Substantially Equivalent on 2007-08-02. Applicant: Gambro Bct, Inc.. Device class: Unclassified.
Clearance details
- Applicant
- Gambro Bct, Inc.
- Product code
- Code LKN
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lakewood, CO, US
Recent devices under product code LKN
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- 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
Adverse 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.