FDA product code LPB: Cardiac Ablation Percutaneous Catheter
LPB is the FDA product code for cardiac ablation percutaneous catheter. It is a Class III device, reviewed by the Cardiovascular panel. Devices under LPB reach the market by PMA; FDA lists no cleared 510(k)s for it. 18 PMA applications cite this product code. FDA has posted 21 recalls for LPB devices.
Definition
This product code pertains to cardiac ablation catheters indicated for general indications, treatment of supraventricular tachycardia (svt) and ventricular tachycardia (vt). This product code excludes ablation catheters indicated for treatment of atrial flutter [product code oad] and atrial fibrillation [product code oae].
Classification
| Field | Value |
|---|---|
| Device name | Cardiac Ablation Percutaneous Catheter |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for LPB devices
21 product recalls in 14 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-09-06.
| Year | Recalls |
|---|---|
| 2017 | 6 |
Frequently asked questions
What is FDA product code LPB?
LPB is the FDA product code for cardiac ablation percutaneous catheter. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is LPB?
Class III. Typical premarket route: PMA.
Have LPB devices been recalled?
Yes: 21 product recalls across 14 recall events; the most recent began 2017-09-06.
Next steps
- Run an FDA pathway report with predicate devices for product code LPB
- Run a recall and safety report across every LPB manufacturer
- Watch product code LPB 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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