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FDA 510(k), K002256, ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP
FDA 510(k), K002256, ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP
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510(K) Number: K002256
Device Name: ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP
Manufacturer: ARROW INTL., INC.
Device Classification Name: system, balloon, intra-aortic and control
Regulation Number: 870.3535
Classification Product Code: DSP
Date Received: 07/25/2000
Decision Date: 05/03/2001
Regulation Medical Specialty: Cardiovascular
Device Name: ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP
Manufacturer: ARROW INTL., INC.
Device Classification Name: system, balloon, intra-aortic and control
Regulation Number: 870.3535
Classification Product Code: DSP
Date Received: 07/25/2000
Decision Date: 05/03/2001
Regulation Medical Specialty: Cardiovascular
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- 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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