SoundBite Crossing System - Peripheral (14P)— 510(k) K210839

Substantially Equivalent

Soundbite Medical Solutions, Inc.

FDA 510(k) clearance K210839 for SoundBite Crossing System - Peripheral (14P), Substantially Equivalent on 2021-04-20. Applicant: Soundbite Medical Solutions, Inc..

Clearance details

Applicant: Soundbite Medical Solutions, Inc.
Product code: Code PDU
Advisory panel: Cardiovascular
Date received: 2021-03-22
Decision date: 2021-04-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Montreal, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code PDU

product code PDU

Malfunction: 793
Total: 793

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.