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.

Cardiovascular › DiagnosticCatheter, Thrombus Retriever

pRESET® Delta Lite Thrombectomy Device (4mm X 20mm)

Name: pRESET® Delta Lite Thrombectomy Device (4mm x 20mm)
Brand: pRESET® Delta Lite Thrombectomy Device (4mm x 20mm)

The pRESET Delta LITE Thrombectomy Device is designed to restore blood flow in the neurovasculature by mechanical removal of thrombus in patients experiencing acute ischemic stroke due to…

Registry build 21.09.26

The pRESET Delta LITE Thrombectomy Device is designed to restore blood flow in the neurovasculature by mechanical removal of thrombus in patients experiencing acute ischemic stroke due to large vessel occlusion with thrombus. The device is designed for use in large vessels of the neurovasculature such as the internal carotid artery (ICA) and middle cerebral artery (MCA).

5manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

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 pRESET® Delta Lite Thrombectomy Device (4mm x 20mm)
Listed by	Phenox Limited, Ireland
FDA product code	NRY
Device type	Catheter, Thrombus Retriever
Device class	Class 2
Regulation	21 CFR 870.1250
Establishment	Complaint-file establishment, Manufacturer
510(k)	K242676
Record published	2025-03-03

Specifications

Specifications
MRI safety	MR Unsafe
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for pRESET® Delta Lite Thrombectomy Device (4mm x 20mm)
Catalogue number	Size	Status
PRE2-LT-4-20	4mm x 20mm	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
K251357	2026-01-15

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.