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

Temporary Non-Roller Type Left Heart Support Blood Pump

Unknown
FDA source (opens on fda.gov)

OZD is the FDA product code for Temporary Non-Roller Type Left Heart Support Blood Pump, a class III device type. FDA's definition for this code reads: "A blood pump that provides temporary full or partial left heart support". As of , FDA records hold no 510(k) clearances under this code and 43 recalls.

Classification record

Product code
OZD
Device name
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA definition
A blood pump that provides temporary full or partial left heart support
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
47

Companies listing this code with FDA

Companies whose registered establishments list this code