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510(k) K222185

Stratus Infusion Catheter by Intervene, Inc. — Product Code NPG

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 13, 2023
Date Received: July 22, 2022
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Catheter, Infusion, Syringe
Device Class: Class II
Regulation Number: 870.1210
Review Panel: CV
Submission Type

To provide physician specified fluids both perivascular or intraluminal to the perivascular space.