FDA 510(k), K171610, MC3 QuickFlow Dual Lumen Catheter
FDA 510(k), K171610, MC3 QuickFlow Dual Lumen Catheter
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510(K) Number: K171610
Device Name: MC3 QuickFlow Dual Lumen Catheter
Manufacturer: MC3 Incorporated
Device Classification Name: dual lumen ecmo cannula
Regulation Number: 870.4100
Classification Product Code: PZS
Date Received: 06/01/2017
Decision Date: 11/16/2017
Regulation Medical Specialty: Cardiovascular
Device Name: MC3 QuickFlow Dual Lumen Catheter
Manufacturer: MC3 Incorporated
Device Classification Name: dual lumen ecmo cannula
Regulation Number: 870.4100
Classification Product Code: PZS
Date Received: 06/01/2017
Decision Date: 11/16/2017
Regulation Medical Specialty: Cardiovascular
- 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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