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FDA 510(k)

SPECTRA OPTIA R APHERESIS SYSTEM

K-Number: K103090 · 2010-11-19

ApplicantCaridianbct, Inc..
Decision Date2010-11-19
Product CodeLKN
DecisionSubstantially Equivalent

Device Summary

SPECTRA OPTIA R APHERESIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Caridianbct, Inc... It received FDA 510(k) clearance on 2010-11-19 under 510(k) number K103090. The device is classified under product code LKN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRA OPTIA R APHERESIS SYSTEM?

SPECTRA OPTIA R APHERESIS SYSTEM is a medical device that received FDA 510(k) clearance on 2010-11-19. The listed applicant is Caridianbct, Inc... The 510(k) number is K103090.

When did SPECTRA OPTIA R APHERESIS SYSTEM receive FDA 510(k) clearance?

SPECTRA OPTIA R APHERESIS SYSTEM received FDA 510(k) clearance on 2010-11-19, under 510(k) number K103090.

Who is the listed applicant for SPECTRA OPTIA R APHERESIS SYSTEM?

The FDA 510(k) record lists Caridianbct, Inc.. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPECTRA OPTIA R APHERESIS SYSTEM?

The FDA product code for SPECTRA OPTIA R APHERESIS SYSTEM is LKN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Caridianbct, Inc.. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K113480SPECTRA OPTIA APHERESIS SYSTEM

Related Devices (Code: LKN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192150AMICUS Separator SystemFresenius Kabi AGK183081Spectra Optia Apheresis SystemTerumobct, Inc.K180615AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer AdapterFresenius Kabi USA,LlcK181049Spectra Optia Apheresis SystemTerumobct, Inc.K172590Spectra Optia Apheresis SystemTerumobct, Inc.K153601Spectra Optia Apheresis SystemTerumobct, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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