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Cardiovascular › ProstheticDevice, Vascular, For Promoting Embolization

Oncozene 100um Oncozene 2ml – US

Catalogue number 11020-US1, listed by Varian Medical Systems, Inc, United States, under Device, Vascular, For Promoting Embolization. 6 manufacturers in China are registered for this product code.

Registry build 21.09.26

6manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (4), Guangdong (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code KRD
Manufacturer	City	Province	Registered as	Device types
Amphenol Alden Products Company	Shenzhen	Guangdong	Contract manufacturer	24
Suzhou Prosteri Medical Technology Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	20
Canyon Medical Inc.	Nanjing	Jiangsu	Manufacturer	4
Suzhou Hengrui Hongyuan Medical Co., Ltd.	Suzhou	Jiangsu	Manufacturer	3
Microport Neurotech (Shanghai) Co., Ltd.	Shanghai	Shanghai	Manufacturer	2
Suzhou Haowei Medical Technology Co., Ltd.	Suzhou	Jiangsu	Manufacturer	1

Record

Regulatory record for Oncozene 100um Oncozene 2mL – US
Listed by	Varian Medical Systems, Inc, United States
FDA product code	KRD
Device type	Device, Vascular, For Promoting Embolization
Device class	Class 2
Regulation	21 CFR 870.3300
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K141209
Record published	2023-05-19
Record revised	2025-10-06 (version 3)

Specifications

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

Catalogue Numbers

Catalogue numbers for Oncozene 100um Oncozene 2mL – US
Catalogue number	Size	Status
11020-US1		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Prestige Coil System	Balt USA, LLC	339
Axium™ Detachable Coil System	Micro Therapeutics, Inc.	279
Optima Coil System	Balt USA, LLC	255
AxiumTM	Micro Therapeutics, Inc.	255
Avenir	Shanghai Wallaby Medical Technologies Co., Inc.	184
MReye	Cook Incorporated	167
Axium™ Prime Detachable Coil System	Micro Therapeutics, Inc.	162
Nester	Cook Incorporated	160
Axium	Micro Therapeutics, Inc.	146
ConcertoTM	Micro Therapeutics, Inc.	133
Tornado	Cook Incorporated	111
V-Trak	MicroVention, Inc.	105

Showing 12 of 158. All products under Device, Vascular, For Promoting Embolization

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K242608	2025-01-17
K242794	2024-10-16

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number	Decision	Trade name	Approved to
P780011	1988-01-29	MINI BALLOON	Bd Becton Dickinson Vacutainer Systems Preanalytic

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.