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510(k) K240050

SOUNDSTAR™ CRYSTAL Ultrasound Catheter by Biosense Webster, Inc. — Product Code OBJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2024
Date Received
January 8, 2024
Clearance Type
Special
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 Biosense Webster, Inc.

  • K252972 — CARTO™ 3 EP Navigation System V8.4 (February 20, 2026)
  • K254085 — CARTO™ 3 EP Navigation System V9.0 with PIU Plus (January 18, 2026)
  • K252302 — CARTO™ 3 EP Navigation System V8.1 (August 22, 2025)
  • K241540 — NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter (June 28, 2024)
  • K231207 — CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) (September 7, 2023)
  • K231312 — PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webs (July 10, 2023)
  • K231412 — CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-13 (July 10, 2023)
  • K230253 — OPTRELL™ Mapping Catheter with TRUEref™ Technology (March 2, 2023)
  • K223733 — CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4 (February 16, 2023)
  • K223766 — NUVISION™ NAV Ultrasound Catheter (February 16, 2023)

Other clearances for product code OBJ

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  • K250955 — XC11 ICE System, USA (October 22, 2025)
  • K250913 — TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System (July 19, 2025)
  • 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)
  • K233948 — Provisio™ SLT IVUS™ System (April 23, 2024)
  • K233270 — AcuNav Crystal Ultrasound Catheter (October 28, 2023)