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FDA 510(k), K963187, MODIFIED LABELING OF CARDIAC ASSIST INTRA-AORTIC BALLOON CATHETERS: MODEL 930 - 940, 30 - 40 CC SENSATION AND NICATH 30C
FDA 510(k), K963187, MODIFIED LABELING OF CARDIAC ASSIST INTRA-AORTIC BALLOON CATHETERS: MODEL 930 - 940, 30 - 40 CC SENSATION AND NICATH 30C
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510(K) Number: K963187
Device Name: MODIFIED LABELING OF CARDIAC ASSIST INTRA-AORTIC BALLOON CATHETERS: MODEL 930 - 940, 30 - 40 CC SENSATION AND NICATH 30C
Manufacturer: BOSTON SCIENTIFIC CORP.
Device Classification Name: system, balloon, intra-aortic and control
Regulation Number: 870.3535
Classification Product Code: DSP
Date Received: 08/14/1996
Decision Date: 11/04/1996
Regulation Medical Specialty: Cardiovascular
Device Name: MODIFIED LABELING OF CARDIAC ASSIST INTRA-AORTIC BALLOON CATHETERS: MODEL 930 - 940, 30 - 40 CC SENSATION AND NICATH 30C
Manufacturer: BOSTON SCIENTIFIC CORP.
Device Classification Name: system, balloon, intra-aortic and control
Regulation Number: 870.3535
Classification Product Code: DSP
Date Received: 08/14/1996
Decision Date: 11/04/1996
Regulation Medical Specialty: Cardiovascular
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