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.

Sofia · Catheter, Thrombus Retriever → Cardiovascular

Name: Sofia
Brand: Sofia

5manufacturers in China registered for this device type

4catalogue 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 Sofia
Listed by	MicroVention, Inc., United States
FDA product code	NRY
Device type	Catheter, Thrombus Retriever
Device class	Class 2
Regulation	21 CFR 870.1250
Establishment	Specification developer, Repacker / relabeller, Manufacturer, Exporter
Record published	2025-04-30
Record revised	2026-04-28 (version 2)

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, manufacturing date
Storage	Special storage condition: Keep Dry. Keep away from sunlight
Sizes	Catheter length 131 cm
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Sofia
Catalogue number	Size	Status
DA6125ST-ASP-US	125cm, STR	In distribution
DA6131ST-ASP-US	131 cm, STR	In distribution
DA6125ST-ASP-US-OD	125cm, STR	In distribution
DA6131ST-ASP-US-OD	Catheter Length 131 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
K211120	2022-03-31
K173200	2018-06-11

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2024-08-05	Class II	Under Investigation by firm	Due to Retrieval Device product labels stating the incorrect expiration dates that (5 years instead of 3 years) which extends beyond their true expiration date.	1,370 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.

Sofia