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FDA 510(k), K093510, LUMENVU CATHETER GUIDANCE SYSTEM
FDA 510(k), K093510, LUMENVU CATHETER GUIDANCE SYSTEM
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510(K) Number: K093510
Device Name: LUMENVU CATHETER GUIDANCE SYSTEM
Manufacturer: SONOSITE,INC.
Device Classification Name: percutaneous, implanted, long-term intravascular catheter accessory for catheter position
Regulation Number: 880.5970
Classification Product Code: OMF
Date Received: 11/12/2009
Decision Date: 08/23/2010
Regulation Medical Specialty: General Hospital
Device Name: LUMENVU CATHETER GUIDANCE SYSTEM
Manufacturer: SONOSITE,INC.
Device Classification Name: percutaneous, implanted, long-term intravascular catheter accessory for catheter position
Regulation Number: 880.5970
Classification Product Code: OMF
Date Received: 11/12/2009
Decision Date: 08/23/2010
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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