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FDA 510(k), K120781, CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH
FDA 510(k), K120781, CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH
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510(K) Number: K120781
Device Name: CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH
Manufacturer: FUJI SYSTEMS CORP.
Device Classification Name: Catheter, Percutaneous
Regulation Number: 870.1250
Classification Product Code: DQY
Date Received: 03/15/2012
Decision Date: 08/09/2012
Regulation Medical Specialty: Cardiovascular
Device Name: CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH
Manufacturer: FUJI SYSTEMS CORP.
Device Classification Name: Catheter, Percutaneous
Regulation Number: 870.1250
Classification Product Code: DQY
Date Received: 03/15/2012
Decision Date: 08/09/2012
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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