Who else makes this device?

Name: Occlusin 500
Brand: Occlusin 500

Cardiovascular › ProstheticDevice, Vascular, For Promoting Embolization

Occlusin 500

Occlusin 500 is a family of biodegradable, dense, hyperechoic microspheres, which are available in a range of calibrated sizes and marketed under the trade name Ekobi Embolization…

Registry build 21.09.26

Occlusin 500 is a family of biodegradable, dense, hyperechoic microspheres, which are available in a range of calibrated sizes and marketed under the trade name Ekobi Embolization Microspheres. The microspheres consist of poly-DL-lactic-co-glycolic acid (PLGA) coated with bovine collagen. Following injection into the target vasculature, the collagen binds circulating platelets resulting in a platelet-rich clot which occludes the target vasculature. The microspheres slowly degrade and are removed from the body over 4-6 months.

6manufacturers in China registered for this device type

7catalogue numbers in this listing

1510(k) clearance

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 Occlusin 500
Listed by	Imbiotechnologies Ltd, Canada
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)	K093813
Record published	2019-01-24
Record revised	2021-02-05 (version 4)

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 a cool, dry location

Catalogue Numbers

Catalogue numbers for Occlusin 500
Catalogue number	Size	Status
Ekobi 504	212-300 µm	In distribution
Ekobi 503P	150-180 µm	In distribution
Ekobi 503L	180-212 µm	In distribution
Ekobi 505	300-425 µm	In distribution
Ekobi 503	150-212 µm	In distribution
Ekobi 501	40-100 µm	In distribution
Ekobi 502		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
K093813	2010-05-10

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.