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.

Socrates · Catheter, Thrombus Retriever → Cardiovascular

Name: Socrates
Brand: Socrates

5manufacturers in China registered for this device type

3catalogue numbers in this listing

2510(k) clearances naming this product code

1recall

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 Socrates
Listed by	Scientia Vascular, United States
FDA product code	NRY
Device type	Catheter, Thrombus Retriever
Device class	Class 2
Regulation	21 CFR 870.1250
Establishment	Manufacturer
510(k)	K223913
Record published	2023-11-14

Specifications

Specifications
MRI safety	MR Unsafe
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 0 to 35 °C; Special storage condition: Keep dry
Sizes	Catheter inner diameter 0.038 in; catheter working length 127 to 156 cm; outer diameter 1.35 mm; outer diameter 0.053 in; catheter inner diameter 0.97 mm; catheter gauge 4 Fr; length 254 cm; length 100 in

Catalogue Numbers

Catalogue numbers for Socrates
Catalogue number	Size	Status
SC038-156-001	Catheter Inner Diameter 0.038 in	In distribution
SC038-127-001	Catheter Inner Diameter 0.038 in	In distribution
TS-254-110	Length 254 cm	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
K260002	2026-07-16
K223913	2023-09-20

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 Socrates
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Scientia Vascular	510(k) number	2025-01-02	Class II	Under Investigation by firm	Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.	120 devices

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.

Socrates