What is FDA product code NRY?

The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode.

Trevo NXT · Catheter, Thrombus Retriever → Cardiovascular

Name: Trevo NXT
Brand: Trevo NXT

5manufacturers in China registered for this device type

3catalogue numbers in this listing

2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Shanghai (3), Jiangsu (2). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code NRY
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
Steris Sterilization Technologies (Suzhou) Ltd	Suzhou	Jiangsu	Contract manufacturer	44
Suzhou Zenith Vascular Scitech Limited	Suzhou	Jiangsu	Manufacturer	6
Shanghai Wallaby Medical Technologies Co., Inc.	Shanghai	Shanghai	Contract manufacturer	5

Record

Regulatory record for Trevo NXT
Listed by	Stryker GmbH, Switzerland
FDA product code	NRY
Device type	Catheter, Thrombus Retriever
Device class	Class 2
Regulation	21 CFR 870.1250
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 28 to 37 mm

Catalogue Numbers

Catalogue numbers for Trevo NXT
Catalogue number	Size	Status
90315	Stent Outer Diameter: 6.0 Millimeter	In distribution
90312	Distal Length: 25.0 Millimeter	In distribution
90313	Stent Outer Diameter: 4.0 Millimeter	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Penumbra System	Penumbra Inc.	100
RED 43	Penumbra Inc.	18
Solitaire™ X-Pack	Micro Therapeutics, Inc.	14
ACE	Penumbra Inc.	14
Raptor Aspiration Catheter	Balt USA, LLC	13
Cereglide	Cerenovus, Inc.	13
Solitaire™	Micro Therapeutics, Inc.	9
Solitaire™ X	Micro Therapeutics, Inc.	9
RED 68	Penumbra Inc.	9
Riptide™	Micro Therapeutics, Inc.	9
Zoom™ Reperfusion Catheter	Imperative Care Inc.	9
CaptureTM	Micro Therapeutics, Inc.	8

Showing 12 of 80. All products under Catheter, Thrombus Retriever

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K183464	2019-03-13
K173841	2018-03-18

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