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FDA 510(k)

SoundBite® Crossing System XS Peripheral

K-Number: K230159 · 2023-08-28

ApplicantSoundbite Medical Solutions, Inc.
Decision Date2023-08-28
Product CodePDU
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SoundBite® Crossing System XS Peripheral is the device name listed in this FDA 510(k) record. The listed applicant is Soundbite Medical Solutions, Inc.. It received FDA 510(k) clearance on 2023-08-28 under 510(k) number K230159. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SoundBite® Crossing System XS Peripheral?

SoundBite® Crossing System XS Peripheral is a medical device that received FDA 510(k) clearance on 2023-08-28. The listed applicant is Soundbite Medical Solutions, Inc.. The 510(k) number is K230159.

When did SoundBite® Crossing System XS Peripheral receive FDA 510(k) clearance?

SoundBite® Crossing System XS Peripheral received FDA 510(k) clearance on 2023-08-28, under 510(k) number K230159.

Who is the listed applicant for SoundBite® Crossing System XS Peripheral?

The FDA 510(k) record lists Soundbite Medical Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SoundBite® Crossing System XS Peripheral?

The FDA product code for SoundBite® Crossing System XS Peripheral is PDU.

Other records listing Soundbite Medical Solutions, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210839SoundBite Crossing System - Peripheral (14P)

Related Devices (Code: PDU)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252315Santreva™-ATK Endovascular Revasculariztion CatheterAngioSafe, Inc.K251158PowerWire® 14 Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.K251376LimFlow ARCLimFlow, Inc.K232562PowerWire Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.K230594Tigereye ST CTO-Crossing CatheterAvinger, Inc.K221163Tunnel Crossing CatheterTractus Vascular, LLC

Official Source

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

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