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510(k) K233350

SINC Support Catheter by Reflow Medical, Inc. — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2024
Date Received
September 29, 2023
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

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  • K173661 — Wingman 35 Crossing Catheter (April 18, 2018)
  • K173662 — speX Support Catheter (December 20, 2017)

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