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510(k) K183599

Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter by Infraredx, Inc. — Product Code OGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2019
Date Received
December 26, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Plaque Morphology Evaluation
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

Catheter used for delivery of a sensing modality to a coronary or peripheral artery region for determination of atherosclerotic plaque characteristics. For examination of morphologic features of coronary or peripheral artery lesions or plaques.

Other clearances by Infraredx, Inc.

  • K241576 — Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS I (February 26, 2025)
  • K213303 — Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Ima (December 7, 2021)
  • 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)
  • K052908 — INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5 (June 23, 2006)

Other clearances for product code OGZ

  • K241576 — Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS I (February 26, 2025)
  • 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)