FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
SoundBite Crossing System - Peripheral (14P)
K Number: K210839
·
Decision Apr 20, 2021
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
56
Applicant Total
2
Review Days
29
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Basic Information
- Device Name
- SoundBite Crossing System - Peripheral (14P)
- K Number
- K210839
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Soundbite Medical Solutions, Inc.
- Date Received
- March 22, 2021
- Decision Date
- April 20, 2021
- Product Code
- PDU
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PDU | Catheter For Crossing Total Occlusions | FDA class 2 | Cardiovascular |
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Other Clearances by Soundbite Medical Solutions, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K230159 | SoundBite® Crossing System XS Peripheral | Aug 28, 2023 | Substantially Equivalent |