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FDA 510(k), K172790, ER-REBOA Catheter
FDA 510(k), K172790, ER-REBOA Catheter
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510(K) Number: K172790
Device Name: ER-REBOA Catheter
Manufacturer: Prytime Medical Devices, Inc.
Device Classification Name: catheter, intravascular occluding, temporary
Regulation Number: 870.4450
Classification Product Code: MJN
Date Received: 09/15/2017
Decision Date: 11/08/2017
Regulation Medical Specialty: Cardiovascular
Device Name: ER-REBOA Catheter
Manufacturer: Prytime Medical Devices, Inc.
Device Classification Name: catheter, intravascular occluding, temporary
Regulation Number: 870.4450
Classification Product Code: MJN
Date Received: 09/15/2017
Decision Date: 11/08/2017
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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