FDA 510(k), K161126, ASAHI Corsair Pro
FDA 510(k), K161126, ASAHI Corsair Pro
510(K) Number: K161126
Device Name: ASAHI Corsair Pro
Manufacturer: CARROLL COUNCILMAN
Device Classification Name: Catheter, Percutaneous
Regulation Number: DQY
Classification Product Code: KXA
Date Received: 04/21/2016
Decision Date: 08/25/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Total pages: 244
Fully redacted pages: 175
Content pages: 69
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