FDA 510(k), K131482, SOFIA DISTAL ACCESS CATHETER
FDA 510(k), K131482, SOFIA DISTAL ACCESS CATHETER
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510(K) Number: K131482
Device Name: SOFIA DISTAL ACCESS CATHETER
Manufacturer:
Device Classification Name: Catheter, Percutaneous
Regulation Number: 870.1250
Classification Product Code: DQY
Date Received: 05/23/2013
Decision Date: 11/22/2013
Regulation Medical Specialty: Cardiovascular
Device Name: SOFIA DISTAL ACCESS CATHETER
Manufacturer:
Device Classification Name: Catheter, Percutaneous
Regulation Number: 870.1250
Classification Product Code: DQY
Date Received: 05/23/2013
Decision Date: 11/22/2013
Regulation Medical Specialty: Cardiovascular