FDA product code PIZ: Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve
PIZ is the FDA product code for combination compression/decompression manual chest pump with impedance respiratory valve. It is a Class III device, reviewed by the Cardiovascular panel. Devices under PIZ reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
Intended for use as a CPR adjunct to improve the likelihood of survival in adult patients with non-traumatic cardiac arrest.
Classification
| Field | Value |
|---|---|
| Device name | Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Life-sustaining or supporting | Yes |
Recalls for PIZ devices
openFDA lists no recalls for product code PIZ.
Frequently asked questions
What is FDA product code PIZ?
PIZ is the FDA product code for combination compression/decompression manual chest pump with impedance respiratory valve. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is PIZ?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code PIZ
- Run a recall and safety report across every PIZ manufacturer
- Watch product code PIZ 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.
All Cardiovascular product codes · FDA product code lookup · 510(k) database search · 510(k) review times