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

Temporary Non-Roller Type Right Heart Support Blood Pump

21 CFR 870.4360 / Cardiovascular
FDA source (opens on fda.gov)

PYX is the FDA product code for Temporary Non-Roller Type Right Heart Support Blood Pump, a class III device type, regulated under 21 CFR 870.4360. FDA's definition for this code reads: "Providing temporary partial or full right heart circulatory support". As of , FDA records hold no 510(k) clearances under this code and 7 recalls.

Classification record

Product code
PYX
Device name
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA definition
Providing temporary partial or full right heart circulatory support.
Regulation
21 CFR 870.4360
Device class
Class III
Review panel
Cardiovascular
Submission type
PMA
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
7

Companies listing this code with FDA

Companies whose registered establishments list this code