FDA product code NTE: Temporary Carotid Catheter For Embolic Capture
NTE is the FDA product code for temporary carotid catheter for embolic capture. It is a Class II device, regulated under 21 CFR 870.1250 and reviewed by the Cardiovascular panel. FDA has cleared 36 510(k) submissions under NTE, 3 in the last five years, from 22 different applicants. The average 510(k) review took 66 days (median 43). FDA has posted 30 recalls for NTE devices, 20 initiated in the last five years.
Definition
This device is a single use percutaneous catheter system that is introduced into an artery through the skin using a guidewire. The catheter has an embolic capture filter or an occlusion balloon at the distal end. The filter or balloon can be placed either distally to the lesion or proximally depending on the design of the device and intended use. The filter or balloon is used to capture embolic material in a manner that may protect or prevent a stroke or other cerebral vascular sequelae. The embolic capture device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures i
Classification
| Field | Value |
|---|---|
| Device name | Temporary Carotid Catheter For Embolic Capture |
| 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 NTE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 77 |
| 2019 | 1 | 85 |
| 2020 | 1 | 51 |
| 2021 | 1 | 30 |
| 2022 | 1 | 30 |
| 2023 | 2 | 144 |
Compare with all 510(k) review times · Search every NTE clearance
Top NTE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Vascular | 4 | 2019-07-25 |
| W. L. Gore & Associates, Inc. | 3 | 2012-12-13 |
| Ev3, Inc. | 3 | 2011-10-27 |
| Cardiovascular Systems, Inc. | 2 | 2021-03-03 |
| Silk Road Medical, Inc. | 2 | 2016-03-10 |
17 more applicants have NTE clearances. See the full list in Caduvo.
Most recent NTE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K222694 | MicroVention, Inc. | EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) | 2023-04-27 | 233 |
| K230402 | Silk Road Medical | ENROUTE® Transcarotid Neuroprotection System | 2023-04-11 | 55 |
| K220654 | Cordis Corporation | ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire | 2022-04-06 | 30 |
| K210282 | Cardiovascular Systems, Inc. | WIRION Embolic Protection System | 2021-03-03 | 30 |
| K200198 | Cardiovascular Systems, Inc. | WIRION | 2020-03-18 | 51 |
Recalls for NTE devices
30 product recalls in 7 recall events; 20 initiated in the last five years and 19 still open. Most recent: 2026-07-09.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2023 | 17 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code NTE?
NTE is the FDA product code for temporary carotid catheter for embolic capture. It is a Class II device, regulated under 21 CFR 870.1250 and reviewed by the Cardiovascular panel.
What device class is NTE?
Class II, regulation 21 CFR 870.1250. Typical premarket route: 510(k).
How long does a 510(k) take for product code NTE?
Across 36 cleared submissions the average was 66 days from receipt to decision (median 43).
Which companies have the most NTE clearances?
Abbott Vascular (4); W. L. Gore & Associates, Inc. (3); Ev3, Inc. (3); Cardiovascular Systems, Inc. (2); Silk Road Medical, Inc. (2).
Have NTE devices been recalled?
Yes: 30 product recalls across 7 recall events; the most recent began 2026-07-09.
Next steps
- Run an FDA pathway report with predicate devices for product code NTE
- Run a recall and safety report across every NTE manufacturer
- Watch product code NTE 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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