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510(k) K252945

Novasight Hybrid System by Conavi Medical, Inc. — Product Code OBJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2026
Date Received
September 15, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.

Other clearances by Conavi Medical, Inc.

  • K172258 — Novasight Hybrid System (April 27, 2018)
  • K162789 — Foresight Intracardiac Echocardiology (ICE) System (March 28, 2017)

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  • K250955 — XC11 ICE System, USA (October 22, 2025)
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  • K251211 — ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD (May 23, 2025)
  • K251231 — ViewFlex™ X ICE Catheter, Sensor Enabled™ (May 20, 2025)
  • K251103 — VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intrac (May 9, 2025)
  • K242893 — VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System (March 24, 2025)
  • K241540 — NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter (June 28, 2024)
  • K240050 — SOUNDSTAR™ CRYSTAL Ultrasound Catheter (June 12, 2024)