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FDA 510(k), K212324, RenovoCath
FDA 510(k), K212324, RenovoCath
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510(K) Number: K212324
Device Name: RenovoCath
Manufacturer: RenovoRx, Inc.
Device Classification Name: Catheter, Intravascular Occluding, Temporary
Regulation Number: 870.4450
Classification Product Code: MJN
Date Received: 07/26/2021
Decision Date: 08/23/2021
Regulation Medical Specialty: Cardiovascular
Device Name: RenovoCath
Manufacturer: RenovoRx, Inc.
Device Classification Name: Catheter, Intravascular Occluding, Temporary
Regulation Number: 870.4450
Classification Product Code: MJN
Date Received: 07/26/2021
Decision Date: 08/23/2021
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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