What is FDA product code POL?

A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature.

Trevo NXT · Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment → Neurology

Name: Trevo NXT
Brand: Trevo NXT

2manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

Who Else Makes It

All of them in Shanghai. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code POL
Manufacturer	City	Province	Registered as	Device types
Covidien Medical Products (Shanghai) Manufacturing LLC	Shanghai	Shanghai	Contract manufacturer	8
Sterigenics Shanghai ETO Ltd.	Shanghai	Shanghai	Contract manufacturer	65

Record

Regulatory record for Trevo NXT
Listed by	Stryker GmbH, Switzerland
FDA product code	POL
Device type	Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Device class	Class 2
Regulation	21 CFR 882.5600
Establishment	Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer
510(k)	K192207
Record published	2020-04-20
Record revised	2026-01-12 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Special storage condition: Store in cool, dry, dark place.
Sizes	Stent length 41 mm

Catalogue Numbers

Catalogue numbers for Trevo NXT
Catalogue number	Size	Status
90314	Stent Length 41.0 mm	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Solitaire™ X-Pack	Micro Therapeutics, Inc.	11
Solitaire ™ Platinum	Micro Therapeutics, Inc.	9
Solitaire™	Micro Therapeutics, Inc.	5
Solitaire™ X	Micro Therapeutics, Inc.	5
pRESET® Lite Thrombectomy Device (4mm x 20mm)	Phenox Limited	1
pRESET® Lite Thrombectomy Device (3mm x 20mm)	Phenox Limited	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K200117	2020-02-07
K192207	2019-11-22
K190779	2019-06-25

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Trevo NXT
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Stryker Neurovascular	510(k) number	2024-04-23	Class II	Process design	Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin l	204

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Trevo NXT