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

Ventricular Bypass (Assist) Device

21 CFR 870.3545 / Cardiovascular
FDA source (opens on fda.gov)

OKR is the FDA product code for Ventricular Bypass (Assist) Device, a class III device type, regulated under 21 CFR 870.3545. FDA's definition for this code reads: "A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow for <6 hours. The device is either totally or partially implanted in the body". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
OKR
Device name
Ventricular Bypass (Assist) Device
FDA definition
A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow for <6 hours. The device is either totally or partially implanted in the body.
Regulation
21 CFR 870.3545
Device class
Class III
Review panel
Cardiovascular
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code OKR.