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510(k) K201811

coraForce and coraFlex Support Catheters by Reflow Medical, Inc. — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2020
Date Received
July 1, 2020
Clearance Type
Traditional
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 Reflow Medical, Inc.

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  • K233350 — SINC Support Catheter (February 8, 2024)
  • K210188 — coraCross (May 28, 2021)
  • K200094 — speX LP Support Catheter (March 18, 2020)
  • K193596 — Wingman 14, Wingman 14C, Wingman 18, Wingman 35 (February 20, 2020)
  • K193012 — speX Support Catheter (February 19, 2020)
  • K190393 — Wingman 14C Crossing Catheter (May 9, 2019)
  • K173661 — Wingman 35 Crossing Catheter (April 18, 2018)
  • K173662 — speX Support Catheter (December 20, 2017)

Other clearances for product code DQY

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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)
  • K250492 — FlexiGo 3D Delivery Catheter (June 18, 2025)