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FDA 510(k), K874927, PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET
FDA 510(k), K874927, PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET
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510(K) Number: K874927
Device Name: PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET
Manufacturer: PIONEERING TECHNOLOGIES, INC.
Device Classification Name: controller, temperature, cardiopulmonary bypass
Regulation Number: 870.4250
Classification Product Code: DWC
Date Received: 12/02/1987
Decision Date: 01/29/1988
Regulation Medical Specialty: Cardiovascular
Device Name: PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET
Manufacturer: PIONEERING TECHNOLOGIES, INC.
Device Classification Name: controller, temperature, cardiopulmonary bypass
Regulation Number: 870.4250
Classification Product Code: DWC
Date Received: 12/02/1987
Decision Date: 01/29/1988
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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