FDA product code QFV: Implantable Pulse Generator
QFV is the FDA product code for implantable pulse generator. It is a Class III device, reviewed by the Cardiovascular panel. Devices under QFV reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 1 recall for QFV devices, 1 initiated in the last five years.
Definition
Deliver Cardiac Contractility Modulation signals during the absolute refractory period
Classification
| Field | Value |
|---|---|
| Device name | Implantable Pulse Generator |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for QFV devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-01-05.
| Year | Recalls |
|---|---|
| 2024 | 1 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- C1767 — Generator, neurostimulator (implantable), non-rechargeable
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system
- C8009 — Removal of hypoglossal nerve neurostimulator array and pulse generator
Frequently asked questions
What is FDA product code QFV?
QFV is the FDA product code for implantable pulse generator. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is QFV?
Class III. Typical premarket route: PMA.
Have QFV devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-01-05.
Next steps
- Run an FDA pathway report with predicate devices for product code QFV
- Run a recall and safety report across every QFV manufacturer
- Watch product code QFV 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.
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