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FDA 510(k), K961509, INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED
FDA 510(k), K961509, INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED
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510(K) Number: K961509
Device Name: INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED
Manufacturer: DATASCOPE CORP.
Device Classification Name: system, balloon, intra-aortic and control
Regulation Number: 870.3535
Classification Product Code: DSP
Date Received: 04/19/1996
Decision Date: 11/15/1996
Regulation Medical Specialty: Cardiovascular
Device Name: INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED
Manufacturer: DATASCOPE CORP.
Device Classification Name: system, balloon, intra-aortic and control
Regulation Number: 870.3535
Classification Product Code: DSP
Date Received: 04/19/1996
Decision Date: 11/15/1996
Regulation Medical Specialty: Cardiovascular
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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