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510(k) K250492

FlexiGo 3D Delivery Catheter by CenterPoint Systems, LLC — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2025
Date Received
February 20, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

Other clearances by CenterPoint Systems, LLC

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  • K251051 — AuST Steerable Sheath (April 30, 2025)
  • K243180 — SSPC NXT Delivery Catheter (December 4, 2024)
  • K242106 — AuST Steerable Sheath (October 4, 2024)
  • K233752 — Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ I (May 2, 2024)
  • K240829 — AuST Steerable Sheath (May 1, 2024)
  • K223097 — RenaNav Ureteroscope System (July 31, 2023)
  • K230363 — CPS Locator 3D Delivery Catheter (March 9, 2023)

Other clearances for product code DQY

  • K260499 — Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609- (March 13, 2026)
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  • K252417 — Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) (December 17, 2025)
  • K252390 — Telescope Guide Extension Catheter (October 29, 2025)
  • K250147 — CPS Locator 3D Delivery Catheter (August 22, 2025)
  • K251277 — CoraForce Microcatheter, CoraFlex Microcatheter (August 22, 2025)
  • K250972 — Primum Hydrophilic Guiding Catheter (June 29, 2025)
  • K250828 — CPS Locator 3D Plus Delivery Catheter (June 27, 2025)
  • K243184 — SAT CenterFlow Molding Balloon Catheter (IN20-00313) (June 25, 2025)
  • K250219 — Dorado™ PTA Balloon Dilatation Catheter (June 17, 2025)