K210839 is an FDA 510(k) clearance for the SoundBite Crossing System - Peripheral (14P). Classified as Catheter For Crossing Total Occlusions (product code PDU), Class II - Special Controls.
Submitted by Soundbite Medical Solutions, Inc. (Montreal, CA). The FDA issued a Cleared decision on April 20, 2021 after a review of 29 days - a notably fast clearance cycle.
This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.
Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.
View all Soundbite Medical Solutions, Inc. devices
NCT03266835
Completed
Interventional
Industry-sponsored
SoundBite™ Crossing System Pivotal Peripheral CTO Crossing Study
A Multinational, Single-Arm Pivotal Study to Assess the Performance Rate Of SoundBite™ Active Wire for PEripheral Chronic Total Occlusion Recanalization (PROSPECTOR)
| Condition studied |
Chronic Total Occlusion of Arteries of the Extremities |
| Study design |
Single group |
| Eligibility |
All sexes
· 18 Years+
|
| Sponsor |
SoundBite Medical Solutions, Inc.
(industry)
|
Started 2017-11-16
→
Primary completion 2019-01-18
Primary outcome
Technical Device Success
Secondary outcome
Procedural success
Study completed - no results published.
This trial concluded in 2019 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
Individual participant data will not be shared.
View full study on ClinicalTrials.gov