FDA 510(k), K053501, POWERPICC
FDA 510(k), K053501, POWERPICC
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510(K) Number: K053501
Device Name: POWERPICC
Manufacturer: BARD ACCESS SYSTEMS, INC.
Device Classification Name: catheter, intravascular, therapeutic, long-term greater than 30 days
Regulation Number: 880.5970
Classification Product Code: LJS
Date Received: 12/16/2005
Decision Date: 01/13/2006
Regulation Medical Specialty: General Hospital
Device Name: POWERPICC
Manufacturer: BARD ACCESS SYSTEMS, INC.
Device Classification Name: catheter, intravascular, therapeutic, long-term greater than 30 days
Regulation Number: 880.5970
Classification Product Code: LJS
Date Received: 12/16/2005
Decision Date: 01/13/2006
Regulation Medical Specialty: General Hospital
- 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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