FDA product code PRC: Drug-Coated Peripheral Transluminal Angioplasty Catheter
PRC is the FDA product code for drug-coated peripheral transluminal angioplasty catheter. It is a Class III device, reviewed by the Cardiovascular panel. Devices under PRC reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 1 recall for PRC devices, 1 initiated in the last five years.
Definition
Balloon dilatation of native and/or synthetic arteriovenous dialysis fistulae to establish or maintain patency
Classification
| Field | Value |
|---|---|
| Device name | Drug-Coated Peripheral Transluminal Angioplasty Catheter |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for PRC devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-03-23.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code PRC?
PRC is the FDA product code for drug-coated peripheral transluminal angioplasty catheter. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is PRC?
Class III. Typical premarket route: PMA.
Have PRC devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2022-03-23.
Next steps
- Run an FDA pathway report with predicate devices for product code PRC
- Run a recall and safety report across every PRC manufacturer
- Watch product code PRC 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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