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FDA 510(k), K141634, NAUTILUS DELTA
FDA 510(k), K141634, NAUTILUS DELTA
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510(K) Number: K141634
Device Name: NAUTILUS DELTA
Manufacturer: ROMEDEX INTERNATIONAL SRL
Device Classification Name: catheter, intravascular, therapeutic, long-term greater than 30 days
Regulation Number: 880.5970
Classification Product Code: LJS
Date Received: 06/18/2014
Decision Date: 01/27/2015
Regulation Medical Specialty: General Hospital
Device Name: NAUTILUS DELTA
Manufacturer: ROMEDEX INTERNATIONAL SRL
Device Classification Name: catheter, intravascular, therapeutic, long-term greater than 30 days
Regulation Number: 880.5970
Classification Product Code: LJS
Date Received: 06/18/2014
Decision Date: 01/27/2015
Regulation Medical Specialty: General Hospital
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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