510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PPSClass II

Sleeve, Head And Neck, Compressible

21 CFR 870.5800 / Cardiovascular
FDA source (opens on fda.gov)

PPS is the FDA product code for Sleeve, Head And Neck, Compressible, a class II device type, regulated under 21 CFR 870.5800. FDA's definition for this code reads: "Intended to move excess fluid from the target area to another area of the body". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PPS
Device name
Sleeve, Head And Neck, Compressible
FDA definition
Intended to move excess fluid from the target area to another area of the body.
Regulation
21 CFR 870.5800
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code PPS

By decision year
1 clearance under product code PPS with a decision year between 2016 and 2016, 2016 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PPS by decision year
YearClearances
20161

Applicants with the most clearances

Product code PPS
Applicants holding the most 510(k) clearances under product code PPS
ApplicantClearances
Tactile Systems Technology, Inc. (dba Tactile Medical)1

Companies listing this code with FDA

Companies whose registered establishments list this code