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

Adjunctive Cardiovascular Status Indicator

21 CFR 870.2200 / Cardiovascular
FDA source (opens on fda.gov)

PPW is the FDA product code for Adjunctive Cardiovascular Status Indicator, a class II device type, regulated under 21 CFR 870.2200. FDA's definition for this code reads: "The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy". As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PPW
Device name
Adjunctive Cardiovascular Status Indicator
FDA definition
The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
Regulation
21 CFR 870.2200
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
No
Ingested clearances
8
Ingested recalls
0

Clearances, product code PPW

By decision year
8 clearances under product code PPW with a decision year between 2016 and 2026, 2022 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PPW by decision year
YearClearances
20161
20181
20222
20231
20252
20261

Applicants with the most clearances

Product code PPW
Applicants holding the most 510(k) clearances under product code PPW
ApplicantClearances
Etiometry Inc.4
Flashback Technologies, Inc.3
Prolaio Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code