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CenterPoint Systems, LLC

FDA 510(k) & PMA Approved Devices — 15 products

Total Devices15
Categories4
Latest FDA decision2026-07-29
TypeNumberDevice NameCodeDateActions
510(k) K261766 CPS Locator 3D Plus Delivery CatheterDQY2026-07-29 View
510(k) K262240 SSPC NXT Delivery CatheterDQY2026-07-29 View
510(k) K261492 FieldFlex Steerable SheathDYB2026-06-05 View
510(k) K260942 AuST Steerable SheathDYB2026-04-07 View
510(k) K260163 AuST CSP IntroducerDYB2026-02-19 View
510(k) K250828 CPS Locator 3D Plus Delivery CatheterDQY2025-06-27 View
510(k) K250492 FlexiGo 3D Delivery CatheterDQY2025-06-18 View
510(k) K251051 AuST Steerable SheathDYB2025-04-30 View
510(k) K243180 SSPC NXT Delivery CatheterDQY2024-12-04 View
510(k) K242106 AuST Steerable SheathDYB2024-10-04 View
510(k) K233752 Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel CapsFBN2024-05-02 View
510(k) K240829 AuST Steerable SheathDYB2024-05-01 View
510(k) K223097 RenaNav Ureteroscope SystemFGB2023-07-31 View
510(k) K230363 CPS Locator 3D Delivery CatheterDQY2023-03-09 View
510(k) K210009 Guiding CatheterDQY2021-11-24 View
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