FDA product code QJP: Catheter, Percutaneous, Neurovasculature
QJP is the FDA product code for catheter, percutaneous, neurovasculature. It is a Class II device, regulated under 21 CFR 870.1250 and reviewed by the Neurology panel. FDA has cleared 100 510(k) submissions under QJP, 79 in the last five years, from 44 different applicants. The average 510(k) review took 159 days (median 143); 156 days on average over the last three years. FDA has posted 7 recalls for QJP devices, 7 initiated in the last five years.
Definition
To provide vascular access to the neurovasculature for interventional or diagnostic procedures
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Percutaneous, Neurovasculature |
| Device class | Class II |
| Regulation | 21 CFR 870.1250 |
| Review panel | NE — Neurology |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for QJP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 9 | 75 |
| 2021 | 12 | 156 |
| 2022 | 14 | 216 |
| 2023 | 14 | 169 |
| 2024 | 18 | 192 |
| 2025 | 14 | 132 |
| 2026 | 19 | 143 |
Compare with all 510(k) review times · Search every QJP clearance
Top QJP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Stryker Neurovascular | 9 | 2026-07-01 |
| Route 92 Medical, Inc. | 7 | 2026-09-16 |
| Imperative Care, Inc. | 6 | 2026-08-28 |
| Balt USA, LLC | 6 | 2026-07-13 |
| Asahi Intecc Co., Ltd. | 6 | 2026-05-11 |
39 more applicants have QJP clearances. See the full list in Caduvo.
Most recent QJP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260220 | Route 92 Medical, Inc. | Route 92 Medical Full Length 046 Access System | 2026-09-16 | 233 |
| K262277 | Piraeus Medical, Inc. | 70 NeuGlide Catheter | 2026-09-04 | 60 |
| K261176 | Imperative Care, Inc. | Zoom 4S Catheter | 2026-08-28 | 140 |
| K254071 | Wallaby Medical | p17 XR Microcatheter | 2026-08-18 | 243 |
| K260199 | Balt USA, LLC | SLIM Microcatheter | 2026-07-13 | 172 |
Recalls for QJP devices
7 product recalls in 6 recall events; 7 initiated in the last five years and 7 still open. Most recent: 2025-01-16.
| Year | Recalls |
|---|---|
| 2023 | 1 |
| 2024 | 5 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code QJP?
QJP is the FDA product code for catheter, percutaneous, neurovasculature. It is a Class II device, regulated under 21 CFR 870.1250 and reviewed by the Neurology panel.
What device class is QJP?
Class II, regulation 21 CFR 870.1250. Typical premarket route: 510(k).
How long does a 510(k) take for product code QJP?
Across 100 cleared submissions the average was 159 days from receipt to decision (median 143).
Which companies have the most QJP clearances?
Stryker Neurovascular (9); Route 92 Medical, Inc. (7); Imperative Care, Inc. (6); Balt USA, LLC (6); Asahi Intecc Co., Ltd. (6).
Have QJP devices been recalled?
Yes: 7 product recalls across 6 recall events; the most recent began 2025-01-16.
Next steps
- Run an FDA pathway report with predicate devices for product code QJP
- Run a recall and safety report across every QJP manufacturer
- Watch product code QJP 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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