FDA product code QRH: Catheter, Balloon, Urethral, Drug-Coated
QRH is the FDA product code for catheter, balloon, urethral, drug-coated. It is a Class III device, reviewed by the Gastroenterology and Urology panel. Devices under QRH reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
Dilate urethral strictures
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Balloon, Urethral, Drug-Coated |
| Device class | Class III |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QRH devices
openFDA lists no recalls for product code QRH.
Frequently asked questions
What is FDA product code QRH?
QRH is the FDA product code for catheter, balloon, urethral, drug-coated. It is a Class III device, reviewed by the Gastroenterology and Urology panel.
What device class is QRH?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QRH
- Run a recall and safety report across every QRH manufacturer
- Watch product code QRH 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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