FDA 510(k) Applications Submitted by CenterPoint Systems LLC

FDA 510(k) Number Submission Date Device Name Applicant
K250492 02/20/2025 FlexiGo 3D Delivery Catheter CenterPoint Systems LLC
K250828 03/19/2025 CPS Locator 3D Plus Delivery Catheter CenterPoint Systems LLC
K251051 04/03/2025 AuST Steerable Sheath CenterPoint Systems LLC
K242106 07/18/2024 AuST Steerable Sheath CenterPoint Systems LLC
K243180 09/30/2024 SSPC NXT Delivery Catheter CenterPoint Systems LLC
K233752 11/22/2023 DragonflyÖ Pancreaticobiliary Scope; DragonflyÖ Digital Controller; DragonflyÖ Instrument Channel Caps CenterPoint Systems LLC
K240829 03/26/2024 AuST Steerable Sheath CenterPoint Systems LLC
K210009 01/04/2021 Guiding Catheter CenterPoint Systems LLC
K230363 02/10/2023 CPS Locator 3D Delivery Catheter CenterPoint Systems LLC
K223097 09/30/2022 RenaNav Ureteroscope System CenterPoint Systems LLC


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