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FDA 510(k), K033389, POWERPICC CATHETERS, MODELS 3175155, 3175135
FDA 510(k), K033389, POWERPICC CATHETERS, MODELS 3175155, 3175135
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510(K) Number: K033389
Device Name: POWERPICC CATHETERS, MODELS 3175155, 3175135
Manufacturer: MICHAELA RIVKOWICH
Device Classification Name: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Regulation Number: LJS
Classification Product Code: 10/23/2003
Date Received: 03/19/2004
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: POWERPICC CATHETERS, MODELS 3175155, 3175135
Manufacturer: MICHAELA RIVKOWICH
Device Classification Name: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Regulation Number: LJS
Classification Product Code: 10/23/2003
Date Received: 03/19/2004
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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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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