FDA product code LIT: Catheter, Angioplasty, Peripheral, Transluminal
LIT is the FDA product code for catheter, angioplasty, peripheral, transluminal. It is a Class II device, regulated under 21 CFR 870.1250 and reviewed by the Cardiovascular panel. FDA has cleared 404 510(k) submissions under LIT, 26 in the last five years, from 118 different applicants. The average 510(k) review took 114 days (median 87); 121 days on average over the last three years. 1 PMA application cites this product code. FDA has posted 32 recalls for LIT devices, 5 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Angioplasty, Peripheral, Transluminal |
| Device class | Class II |
| Regulation | 21 CFR 870.1250 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LIT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 9 | 61 |
| 2018 | 6 | 115 |
| 2019 | 4 | 100 |
| 2020 | 9 | 129 |
| 2021 | 4 | 150 |
| 2022 | 8 | 144 |
| 2023 | 6 | 204 |
| 2024 | 6 | 80 |
| 2025 | 3 | 98 |
| 2026 | 3 | 186 |
Compare with all 510(k) review times · Search every LIT clearance
Top LIT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boston Scientific Corp | 38 | 2015-06-15 |
| Cordis Corp. | 25 | 2012-05-04 |
| Vas-Cath, Inc. | 14 | 1998-06-19 |
| Meadox Medicals, Div. Boston Scientific Corp. | 14 | 1997-05-16 |
| C.R. Bard, Inc. | 13 | 2023-01-20 |
113 more applicants have LIT clearances. See the full list in Caduvo.
Most recent LIT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254212 | Kossel Medtech (Suzhou) Co., Ltd. | NC PTA Balloon Dilatation Catheter | 2026-09-16 | 261 |
| K260304 | WAVE Medical AG | WAVE PTA Balloon Catheter | 2026-05-20 | 110 |
| K252512 | ABBOTT MEDICAL | Armada 14 NC PTA Catheter | 2026-02-13 | 186 |
| K251915 | Natec Medical , Ltd. | Amethyst HP PTA OTW 0.035 Catheter | 2025-12-18 | 178 |
| K250706 | Biotronik, Inc. | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter | 2025-04-04 | 25 |
Recalls for LIT devices
32 product recalls in 29 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2025-12-03.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2019 | 3 |
| 2020 | 2 |
| 2021 | 3 |
| 2024 | 2 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code LIT?
LIT is the FDA product code for catheter, angioplasty, peripheral, transluminal. It is a Class II device, regulated under 21 CFR 870.1250 and reviewed by the Cardiovascular panel.
What device class is LIT?
Class II, regulation 21 CFR 870.1250. Typical premarket route: 510(k).
How long does a 510(k) take for product code LIT?
Across 404 cleared submissions the average was 114 days from receipt to decision (median 87).
Which companies have the most LIT clearances?
Boston Scientific Corp (38); Cordis Corp. (25); Vas-Cath, Inc. (14); Meadox Medicals, Div. Boston Scientific Corp. (14); C.R. Bard, Inc. (13).
Have LIT devices been recalled?
Yes: 32 product recalls across 29 recall events; the most recent began 2025-12-03.
Next steps
- Run an FDA pathway report with predicate devices for product code LIT
- Run a recall and safety report across every LIT manufacturer
- Watch product code LIT 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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