Sleeve, Head And Neck, Compressible
The Sleeve, Head And Neck, Compressible is a cardiovascular device intended to move excess fluid from the head and neck area to another area of the body through compression, used in the Cardiovascular specialty. It is classified as FDA Class 2 under 21 CFR 870.5800, requiring 510(k) clearance. The device is eligible for third-party 510(k) review. Product code PPS; not an implant and not life-sustaining.
Research product code PPS in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- PPS
- Device Class
- FDA class 2
- Regulation Number
- 870.5800
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
Intended to move excess fluid from the target area to another area of the body.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K153311 | Flexitouch System | Sep 14, 2016 | Substantially Equivalent | Tactile Systems Technology, Inc. (Dba Tactile Medical) |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.