Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SoundBite Crossing System - Peripheral (14P)

K-Number: K210839 · 2021-04-20

ApplicantSoundbite Medical Solutions, Inc.
Decision Date2021-04-20
Product CodePDU
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SoundBite Crossing System - Peripheral (14P) is a medical device manufactured by Soundbite Medical Solutions, Inc.. It received FDA 510(k) clearance on 2021-04-20 under approval number K210839. 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 - Peripheral (14P)?

SoundBite Crossing System - Peripheral (14P) is a medical device that received FDA 510(k) clearance on 2021-04-20. It is manufactured by Soundbite Medical Solutions, Inc.. The 510(k) number is K210839.

When was SoundBite Crossing System - Peripheral (14P) approved by the FDA?

SoundBite Crossing System - Peripheral (14P) received FDA 510(k) clearance on 2021-04-20, under approval number K210839.

What company makes SoundBite Crossing System - Peripheral (14P)?

SoundBite Crossing System - Peripheral (14P) is manufactured by Soundbite Medical Solutions, Inc..

What is the FDA product code for SoundBite Crossing System - Peripheral (14P)?

The FDA product code for SoundBite Crossing System - Peripheral (14P) is PDU.

Related Clinical Trials

NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT04246281 The RESET Clinical Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Back Pain COMPLETED NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT05150197 Virtual Reality Visual Field Testing as an Alternative in Childhood Eye Disease RECRUITING NCT00453505 Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System COMPLETED NCT04229563 Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease COMPLETED

Related PubMed Literature

PMID: 40077817 Research Progress on Neural Cell Culture Systems. Current neuropharmacology (2025)

Other Devices by Soundbite Medical Solutions, Inc.

K230159SoundBite® Crossing System XS Peripheral

Related Devices (Code: PDU)

K162418Pioneer Plus CatheterPhilips Volcano K161208CROSSER CTO Recanalization CatheterBard Peripheral Vacular, Inc. K170349RA-308 Excimer Laser System, Excimer Laser CatheterRa Medical Systems,Inc K183357XableCath Crossing CatheterXablecath, Inc. K201330Tigereye CTO-Crossing CatheterAvinger, Inc. K192211SoundBite Console, SoundBite Active Wire 18Soundbite Medical Solution, Inc.

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.

↑