SoundBite® Crossing System XS Peripheral— 510(k) K230159
Substantially EquivalentSoundbite Medical Solutions, Inc.
FDA 510(k) clearance K230159 for SoundBite® Crossing System XS Peripheral, Substantially Equivalent on 2023-08-28. Applicant: Soundbite Medical Solutions, Inc.. Device class: 2.
Clearance details
- Applicant
- Soundbite Medical Solutions, Inc.
- Product code
- Code PDU
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montreal, CA
Recent devices under product code PDU
view allMore clearances from Soundbite Medical Solutions, Inc.
view allAdverse events under product code PDU
product code PDU- Malfunction
- 793
- Total
- 793
Source: openFDA MAUDE database, through . 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.