FDA 510(k) Applications Submitted by Michael J. Kallok

FDA 510(k) Number Submission Date Device Name Applicant
K071350 05/14/2007 DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM CARDIOVASCULAR SYSTEMS, INC.
K231538 05/30/2023 FreedomFlow Orbital Circumferential Atherectomy System Cardio Flow, Inc.
K213834 12/09/2021 Cardio Flow Peripheral Guide Wire Cardio Flow, Inc.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact