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FDA 510(k)

SOUNDSTAR™ CRYSTAL Ultrasound Catheter

K-Number: K240050 · 2024-06-12

ApplicantBiosense Webster, Inc.
Decision Date2024-06-12
Product CodeOBJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SOUNDSTAR™ CRYSTAL Ultrasound Catheter is a medical device manufactured by Biosense Webster, Inc.. It received FDA 510(k) clearance on 2024-06-12 under approval number K240050. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOUNDSTAR™ CRYSTAL Ultrasound Catheter?

SOUNDSTAR™ CRYSTAL Ultrasound Catheter is a medical device that received FDA 510(k) clearance on 2024-06-12. It is manufactured by Biosense Webster, Inc.. The 510(k) number is K240050.

When was SOUNDSTAR™ CRYSTAL Ultrasound Catheter approved by the FDA?

SOUNDSTAR™ CRYSTAL Ultrasound Catheter received FDA 510(k) clearance on 2024-06-12, under approval number K240050.

What company makes SOUNDSTAR™ CRYSTAL Ultrasound Catheter?

SOUNDSTAR™ CRYSTAL Ultrasound Catheter is manufactured by Biosense Webster, Inc..

What is the FDA product code for SOUNDSTAR™ CRYSTAL Ultrasound Catheter?

The FDA product code for SOUNDSTAR™ CRYSTAL Ultrasound Catheter is OBJ.

Related Clinical Trials

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Related Devices (Code: OBJ)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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