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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 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 2021-04-20 under 510(k) 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. The listed applicant is Soundbite Medical Solutions, Inc.. The 510(k) number is K210839.

When did SoundBite Crossing System - Peripheral (14P) receive FDA 510(k) clearance?

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

Who is the listed applicant for SoundBite Crossing System - Peripheral (14P)?

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 - Peripheral (14P)?

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

K230159SoundBite® Crossing System XS Peripheral

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.K230159SoundBite® Crossing System XS PeripheralSoundbite Medical Solutions, Inc.K230594Tigereye ST CTO-Crossing CatheterAvinger, Inc.

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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