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FDA 510(k), K160598, REBOA Balloon Catheter
FDA 510(k), K160598, REBOA Balloon Catheter
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$149.00 USD
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510(K) Number: K160598
Device Name: REBOA Balloon Catheter
Manufacturer: NUMED, INC.
Device Classification Name: catheter, intravascular occluding, temporary
Regulation Number: 870.4450
Classification Product Code: MJN
Date Received: 03/02/2016
Decision Date: 06/20/2016
Regulation Medical Specialty: Cardiovascular
Device Name: REBOA Balloon Catheter
Manufacturer: NUMED, INC.
Device Classification Name: catheter, intravascular occluding, temporary
Regulation Number: 870.4450
Classification Product Code: MJN
Date Received: 03/02/2016
Decision Date: 06/20/2016
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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