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FDA 510(k), K153729, 8F FlowGate2 Balloon Guide Catheter
FDA 510(k), K153729, 8F FlowGate2 Balloon Guide Catheter
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$149.00 USD
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510(K) Number: K153729
Device Name: 8F FlowGate2 Balloon Guide Catheter
Manufacturer: CONCENTRIC MEDICAL
Device Classification Name: catheter, percutaneous
Regulation Number: 870.1250
Classification Product Code: DQY
Date Received: 12/28/2015
Decision Date: 01/27/2016
Regulation Medical Specialty: Cardiovascular
Device Name: 8F FlowGate2 Balloon Guide Catheter
Manufacturer: CONCENTRIC MEDICAL
Device Classification Name: catheter, percutaneous
Regulation Number: 870.1250
Classification Product Code: DQY
Date Received: 12/28/2015
Decision Date: 01/27/2016
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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