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FDA 510(k), K093993, LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70
FDA 510(k), K093993, LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70
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510(K) Number: K093993
Device Name: LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70
Manufacturer: STEVEN J CHARTIER
Device Classification Name: Catheter, Intravascular, Plaque Morphology Evaluation
Regulation Number: OGZ
Classification Product Code: KXA
Date Received: 12/24/2009
Decision Date: 06/30/2010
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70
Manufacturer: STEVEN J CHARTIER
Device Classification Name: Catheter, Intravascular, Plaque Morphology Evaluation
Regulation Number: OGZ
Classification Product Code: KXA
Date Received: 12/24/2009
Decision Date: 06/30/2010
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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