FDA 510(k), K940178, PERCOR STAT-DL 9.5 FR.34CC & 40CC /PERCOR STAT-DL 10.5 FR.40CC & 50CC INTRA-AORTIC BALLOON MODIFICATION

FDA 510(k), K940178, PERCOR STAT-DL 9.5 FR.34CC & 40CC /PERCOR STAT-DL 10.5 FR.40CC & 50CC INTRA-AORTIC BALLOON MODIFICATION

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510(K) Number: K940178
Device Name: PERCOR STAT-DL 9.5 FR.34CC & 40CC /PERCOR STAT-DL 10.5 FR.40CC & 50CC INTRA-AORTIC BALLOON MODIFICATION
Manufacturer: DATASCOPE CORP.
Device Classification Name: system, balloon, intra-aortic and control
Regulation Number: 870.3535
Classification Product Code: DSP
Date Received: 01/12/1994
Decision Date: 08/09/1994
Regulation Medical Specialty: Cardiovascular
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.

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