FDA product code PDU: Catheter For Crossing Total Occlusions
PDU is the FDA product code for catheter for crossing total occlusions. It is a Class II device, regulated under 21 CFR 870.1250 and reviewed by the Cardiovascular panel. FDA has cleared 58 510(k) submissions under PDU, 12 in the last five years, from 28 different applicants. The average 510(k) review took 106 days (median 84); 114 days on average over the last three years. FDA has posted 7 recalls for PDU devices, 1 initiated in the last five years.
Definition
To facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subchronic and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, such as angioplasty, atherectomy or stent placement.
Classification
| Field | Value |
|---|---|
| Device name | Catheter For Crossing Total Occlusions |
| Device class | Class II |
| Regulation | 21 CFR 870.1250 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for PDU
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 110 |
| 2019 | 1 | 48 |
| 2020 | 2 | 135 |
| 2021 | 3 | 147 |
| 2022 | 4 | 159 |
| 2023 | 3 | 182 |
| 2024 | 1 | 188 |
| 2025 | 3 | 79 |
| 2026 | 1 | 74 |
Compare with all 510(k) review times · Search every PDU clearance
Top PDU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Avinger, Inc. | 10 | 2023-04-25 |
| Spectranetics Corp. | 7 | 2007-07-11 |
| Ra Medical Systems,Inc | 3 | 2022-06-29 |
| Flowcardia, Inc. | 3 | 2010-02-17 |
| Lumend, Inc. | 3 | 2004-01-07 |
23 more applicants have PDU clearances. See the full list in Caduvo.
Most recent PDU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262013 | Reflow Medical, Inc. | Kiba CTO Crossing Catheter | 2026-08-28 | 74 |
| K252315 | AngioSafe, Inc. | Santreva-ATK Endovascular Revasculariztion Catheter | 2025-09-22 | 59 |
| K251158 | Baylis Medical Technologies, Inc. | PowerWire® 14 Radiofrequency Guidewire Kit | 2025-09-11 | 149 |
| K251376 | LimFlow, Inc. | LimFlow ARC | 2025-05-31 | 29 |
| K232562 | Baylis Medical Technologies, Inc. | PowerWire Radiofrequency Guidewire Kit | 2024-02-28 | 188 |
Recalls for PDU devices
7 product recalls in 7 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-11-14.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 3 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code PDU?
PDU is the FDA product code for catheter for crossing total occlusions. It is a Class II device, regulated under 21 CFR 870.1250 and reviewed by the Cardiovascular panel.
What device class is PDU?
Class II, regulation 21 CFR 870.1250. Typical premarket route: 510(k).
How long does a 510(k) take for product code PDU?
Across 58 cleared submissions the average was 106 days from receipt to decision (median 84).
Which companies have the most PDU clearances?
Avinger, Inc. (10); Spectranetics Corp. (7); Ra Medical Systems,Inc (3); Flowcardia, Inc. (3); Lumend, Inc. (3).
Have PDU devices been recalled?
Yes: 7 product recalls across 7 recall events; the most recent began 2023-11-14.
Next steps
- Run an FDA pathway report with predicate devices for product code PDU
- Run a recall and safety report across every PDU manufacturer
- Watch product code PDU 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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