PPS — Sleeve, Head And Neck, Compressible Class II
FDA product code PPS covers "Sleeve, Head And Neck, Compressible", a Class II medical device regulated under 21 CFR 870.5800. Submissions are reviewed by the Cardiovascular panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PPS
- Device Class
- Class II
- Regulation Number
- 870.5800
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
Intended to move excess fluid from the target area to another area of the body.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K153311 | tactile systems technology, inc. (dba tactile medical) | Flexitouch System | September 14, 2016 |