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FDA 510(k), K170349, RA-308 Excimer Laser System, Excimer Laser Catheter
FDA 510(k), K170349, RA-308 Excimer Laser System, Excimer Laser Catheter
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510(K) Number: K170349
Device Name: RA-308 Excimer Laser System, Excimer Laser Catheter
Manufacturer: Ra Medical Systems, Inc.
Device Classification Name: catheter for crossing total occlusions
Regulation Number: 870.1250
Classification Product Code: PDU
Date Received: 02/03/2017
Decision Date: 05/24/2017
Regulation Medical Specialty: Cardiovascular
Device Name: RA-308 Excimer Laser System, Excimer Laser Catheter
Manufacturer: Ra Medical Systems, Inc.
Device Classification Name: catheter for crossing total occlusions
Regulation Number: 870.1250
Classification Product Code: PDU
Date Received: 02/03/2017
Decision Date: 05/24/2017
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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