FDA product code OVG: Magnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml)
OVG is the FDA product code for magnetic cell selection system for cd34+ cells from hpc-apheresis used in treatment of acute myeloid leukemia (aml). It is a HDE device, reviewed by the Hematology panel. Devices under OVG reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
Definition
For processing hematopoietic progenitor cells-apheresis (HPC-A) from an HLA-identical donor to obtain a CD34 positive cell enriched population that will provide for hematopoietic reconstitution following a myeloablative preparative regimen without the need for additional graft-vs-host disease (GVHD) prophylaxis.
Classification
| Field | Value |
|---|---|
| Device name | Magnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml) |
| Device class | HDE |
| Review panel | HE — Hematology |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
Recalls for OVG devices
openFDA lists no recalls for product code OVG.
Frequently asked questions
What is FDA product code OVG?
OVG is the FDA product code for magnetic cell selection system for cd34+ cells from hpc-apheresis used in treatment of acute myeloid leukemia (aml). It is a HDE device, reviewed by the Hematology panel.
What device class is OVG?
HDE. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code OVG
- Run a recall and safety report across every OVG manufacturer
- Watch product code OVG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.