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FDA 510(k), K191606, RenovoCath
FDA 510(k), K191606, RenovoCath
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510(K) Number: K191606
Device Name: RenovoCath
Manufacturer: Kamran Najmabadi
Device Classification Name: Catheter, Intravascular Occluding, Temporary
Regulation Number: MJN
Classification Product Code: KXA
Date Received: 06/17/2019
Decision Date: 08/07/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: RenovoCath
Manufacturer: Kamran Najmabadi
Device Classification Name: Catheter, Intravascular Occluding, Temporary
Regulation Number: MJN
Classification Product Code: KXA
Date Received: 06/17/2019
Decision Date: 08/07/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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