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FDA 510(k), K143405, Option (TM) ELITE Vena Cava Filter 100cm System
FDA 510(k), K143405, Option (TM) ELITE Vena Cava Filter 100cm System
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$149.00 USD
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$149.00 USD
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510(K) Number: K143405
Device Name: Option (TM) ELITE Vena Cava Filter 100cm System
Manufacturer: REX MEDICAL, LP
Device Classification Name: filter, intravascular, cardiovascular
Regulation Number: 870.3375
Classification Product Code: DTK
Date Received: 11/28/2014
Decision Date: 04/16/2015
Regulation Medical Specialty: Cardiovascular
Device Name: Option (TM) ELITE Vena Cava Filter 100cm System
Manufacturer: REX MEDICAL, LP
Device Classification Name: filter, intravascular, cardiovascular
Regulation Number: 870.3375
Classification Product Code: DTK
Date Received: 11/28/2014
Decision Date: 04/16/2015
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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