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510(k) K052908

INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5 by Infraredx, Inc. — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2006
Date Received
October 14, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

Other clearances by Infraredx, Inc.

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  • K213303 — Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Ima (December 7, 2021)
  • K183599 — Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter (April 12, 2019)
  • K163345 — TVC Imaging System, TVC Catheter (June 21, 2017)
  • K141682 — TVC IMAGING SYSTEM, TVC INSIGHT CATHETER (November 24, 2014)
  • K133897 — TVC IMAGING SYSTEM, TVC INSIGHT CATHETER (April 23, 2014)
  • K130719 — TVC IMAGING SYSTEM, TVC INSIGHT CATHETER (October 17, 2013)
  • K123108 — TVC IMAGING SYSTEM MODEL NIRS-MC7-70 (March 15, 2013)
  • K093993 — LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70 (June 30, 2010)
  • K072932 — INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5 (April 25, 2008)

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  • K233975 — Zoom 6F Insert Catheters (April 2, 2024)
  • K232536 — Soldier Microcatheter (February 23, 2024)
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  • K230620 — Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter (August 8, 2023)
  • K231293 — Drakon™ and Sequre® Microcatheters (June 1, 2023)
  • K230411 — Dragonfly OpStar™ Imaging Catheter (April 14, 2023)