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FDA 510(k), K183045, Eclipse 2L
FDA 510(k), K183045, Eclipse 2L
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$149.00 USD
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$149.00 USD
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510(K) Number: K183045
Device Name: Eclipse 2L
Manufacturer: Balt USA, LLC
Device Classification Name: Catheter, Intravascular Occluding, Temporary
Regulation Number: 870.4450
Classification Product Code: MJN
Date Received: 11/02/2018
Decision Date: 04/30/2019
Regulation Medical Specialty: Cardiovascular
Device Name: Eclipse 2L
Manufacturer: Balt USA, LLC
Device Classification Name: Catheter, Intravascular Occluding, Temporary
Regulation Number: 870.4450
Classification Product Code: MJN
Date Received: 11/02/2018
Decision Date: 04/30/2019
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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