FDA product code DQP: Kit, Balloon Repair, Catheter
DQP is the FDA product code for kit, balloon repair, catheter. It is a Class III device, regulated under 21 CFR 870.1350 and reviewed by the Cardiovascular panel. Devices under DQP reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Call for PMAs 12/26/96 (61 FR 50706 (9/27/96))
Classification
| Field | Value |
|---|---|
| Device name | Kit, Balloon Repair, Catheter |
| Device class | Class III |
| Regulation | 21 CFR 870.1350 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | PMA |
Recalls for DQP devices
openFDA lists no recalls for product code DQP.
Frequently asked questions
What is FDA product code DQP?
DQP is the FDA product code for kit, balloon repair, catheter. It is a Class III device, regulated under 21 CFR 870.1350 and reviewed by the Cardiovascular panel.
What device class is DQP?
Class III, regulation 21 CFR 870.1350. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code DQP
- Run a recall and safety report across every DQP manufacturer
- Watch product code DQP 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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