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
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
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