FDA product code · Cardiovascular
Cardiac Ablation Percutaneous Catheter
13 FDA decisions since 1994. 20 recalls name this code, 0 of them Class I.
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].
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of LPB at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · LPB
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPB
Too few LPB 510(k)s in any year since 2007 to give a median.
Recalls per year · LPB
6in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPB
1,190in 2025
MAUDE reports naming product code LPB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 22 | — | 0 | 61 |
| 2008 | 20 | — | 4 | 75 |
| 2009 | 31 | — | 2 | 76 |
| 2010 | 45 | — | 1 | 63 |
| 2011 | 57 | — | 4 | 102 |
| 2012 | 38 | — | 0 | 248 |
| 2013 | 63 | — | 0 | 406 |
| 2014 | 85 | — | 1 | 799 |
| 2015 | 85 | — | 0 | 1,189 |
| 2016 | 54 | — | 0 | 1,010 |
| 2017 | 46 | — | 6 | 1,115 |
| 2018 | 35 | — | 0 | 975 |
| 2019 | 30 | — | 0 | 1,124 |
| 2020 | 33 | — | 0 | 1,182 |
| 2021 | 39 | — | 0 | 1,240 |
| 2022 | 25 | — | 0 | 1,336 |
| 2023 | 22 | — | 0 | 1,500 |
| 2024 | 18 | — | 0 | 1,839 |
| 2025 | 15 | — | 0 | 1,190 |
| 2026 | 8 | — | 0 | — |
Planning a device in LPB? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report