Device, Vascular, for Promoting Embolization

Which Manufacturers in China Make This?

6 manufacturers in China hold an FDA registration for this device type, concentrated in Jiangsu, Guangdong and Shanghai. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.

Amphenol Alden Products Company Guangdong, contract manufacturer
Canyon Medical Inc. Jiangsu
Microport Neurotech (Shanghai) Co., Ltd. Shanghai
Suzhou Haowei Medical Technology Co., Ltd. Jiangsu
Suzhou Hengrui Hongyuan Medical Co., Ltd. Jiangsu
Suzhou Prosteri Medical Technology Co., Ltd. Jiangsu, contract manufacturer

How Is KRD Classified?

Device, Vascular, For Promoting Embolization is FDA product code KRD, Class 2, 21 CFR 870.3300.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 5 clearances under this code; the FDA took a median of 242 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 19 recalls under this product code since 2005. None was by a company in China. 1 is Class I, the most serious grade.

The root causes the FDA records most often are Process control (2), Software Manufacturing/Software Deployment (1) and Material/Component Contamination (1). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Device, Vascular, For Promoting Embolization

Hourglass Peripheral Embolization Device

Catalogue number PEP-002-US, listed by Embolic Acceleration, LLC, United States, under Device, Vascular, For Promoting Embolization. 6 manufacturers in China are registered for this product code.

Device, Vascular, For Promoting Embolization

Oncozene 40um Oncozene 3ml – US

Catalogue number 10430-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.

Device, Vascular, For Promoting Embolization

Device, Vascular, for Promoting Embolization

Connecting Cable 157cm Contents: 1 Connecting Cable

Device, Vascular, For Promoting Embolization

Embozene Color Advance 75um Embozene 2ml Colored – US

Catalogue number 10720-S1, listed by Varian Medical Systems, Inc, United States, under Device, Vascular, For Promoting Embolization. 6 manufacturers in China are registered for this product code.

Device, Vascular, For Promoting Embolization

Bead Block™

Catalogue number EB2S305-US, listed by Boston Scientific Corporation, United States, under Device, Vascular, For Promoting Embolization. 6 manufacturers in China are registered for this product code.

Device, Vascular, For Promoting Embolization

Multi-Loop – 18

Catalogue number M0013120430, listed by Boston Scientific Corporation, United States, under Device, Vascular, For Promoting Embolization. 6 manufacturers in China are registered for this product code.

Device, Vascular, For Promoting Embolization

EDG V4

ELECTRO DETACH GENERATOR v4 (Model: “EDG v4”) is used to detach the platinum coil from the pusher of i-ED COIL manufactured by Kaneka Corporation.

Device, Vascular, For Promoting Embolization

Embozene Color Advance 400um Embozene 1ml Colored – US

Catalogue number 14010-S1, listed by Varian Medical Systems, Inc, United States, under Device, Vascular, For Promoting Embolization. 6 manufacturers in China are registered for this product code.

Device, Vascular, For Promoting Embolization

Cerepaktm

CEREPAKTM detacher

Device, Vascular, For Promoting Embolization

Intersept®

Filter 7260 Medtronic O2 Sterile 25PK

Device, Vascular, For Promoting Embolization

Oncozene 100um Oncozene 3ml – US

Catalogue number 11030-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.

Device, Vascular, For Promoting Embolization

QuadraSphere Q2™

Catalogue number 00884450299494, listed by Biosphere Medical, Inc., United States, under Device, Vascular, For Promoting Embolization. 6 manufacturers in China are registered for this product code.

Device, Vascular, For Promoting Embolization

Embozene Color Advance 900um Embozene 2ml Colored – US

Catalogue number 19020-S1, listed by Varian Medical Systems, Inc, United States, under Device, Vascular, For Promoting Embolization. 6 manufacturers in China are registered for this product code.

Device, Vascular, For Promoting Embolization

Figure 8 – 18

Catalogue number M0013120210, listed by Boston Scientific Corporation, United States, under Device, Vascular, For Promoting Embolization. 6 manufacturers in China are registered for this product code.

Device, Vascular, For Promoting Embolization

Ruby

Ruby Standard, 20mm x 60cm

Device, Vascular, For Promoting Embolization

Optima Coil System (OptiOne Coil System)

Catalogue number OPTIONE3S, listed by Balt USA, LLC, United States, under Device, Vascular, For Promoting Embolization. 6 manufacturers in China are registered for this product code.

Device, Vascular, For Promoting Embolization

Azur Vacular Plug

The AZUR Vascular Plug is implanted to reduce or block blood flow in arteries of the peripheral vasculature. It is delivered to the treatment site through a microcatheter and remains in the…

Device, Vascular, For Promoting Embolization

Flipper

Flipper, Delivery System

Device, Vascular, For Promoting Embolization

Embozene Color Advance 500um Embozene 1ml Colored – US

Catalogue number 15010-S1, listed by Varian Medical Systems, Inc, United States, under Device, Vascular, For Promoting Embolization. 6 manufacturers in China are registered for this product code.

Device, Vascular, For Promoting Embolization

MicroPearl

Bland Beads

Device, Vascular, For Promoting Embolization

Azur Detachment Controller

3 catalogue numbers from 45-4001-AL, listed by MicroVention, Inc., United States, under Device, Vascular, For Promoting Embolization. 6 manufacturers in China are registered for this product code.

Device, Vascular, For Promoting Embolization

Deltaplush

DELTAPLUSH microcoil DELTAPLUSH 10 Stretch Resistant Coil 1.5mm x 2cm 190cm Contents: 1 Detachable Coil System

Device, Vascular, For Promoting Embolization

Siege™

3 catalogue numbers from Initial Release, listed by Merit Medical Systems, Inc., United States, under Device, Vascular, For Promoting Embolization. 6 manufacturers in China are registered for this product code.

Device, Vascular, For Promoting Embolization

MVP®

Vascular Plug MVP-7Q Mechanical 7MM V02

Device, Vascular, For Promoting Embolization

Orbit Galaxy Enpower Xtrasoft

ORBIT GALAXY G2 microcoil Stretch Resistant Complex XTRASOFT Coil with Tight Distal Loop Technology 4mm x 10cm 190cm Contents: 1 Detachable Coil System Coil Type: Stretch Resistant Complex…

Device, Vascular, For Promoting Embolization

MicroPlex VFC

Catalogue number 8310-2060-A1, listed by MicroVention, Inc., United States, under Device, Vascular, For Promoting Embolization. 6 manufacturers in China are registered for this product code.

Device, 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.

Device, Vascular, For Promoting Embolization

Embozene Color Advance 40um Embozene 1ml Colored – US

Catalogue number 10410-S1, listed by Varian Medical Systems, Inc, United States, under Device, Vascular, For Promoting Embolization. 6 manufacturers in China are registered for this product code.

Device, Vascular, For Promoting Embolization

Amplatzer™

Vascular Plug II

Device, Vascular, For Promoting Embolization

Emba Hourglass Peripheral Embolization Device

Catalogue number PEP-001-US, listed by Embolic Acceleration, LLC, United States, under Device, Vascular, For Promoting Embolization. 6 manufacturers in China are registered for this product code.

Device, Vascular, For Promoting Embolization

LC Bead Lumi 100 – 300

Catalogue number RO2L103, listed by Biocompatibles UK Limited, United States, under Device, Vascular, For Promoting Embolization. 6 manufacturers in China are registered for this product code.

Device, Vascular, For Promoting Embolization

VortX™ Diamond – 18

4 catalogue numbers from M0013822030, listed by Boston Scientific Corporation, United States, under Device, Vascular, For Promoting Embolization. 6 manufacturers in China are registered for this product code.

Device, Vascular, For Promoting Embolization

Micro Plug Set

Micro Plug Set - 5mm

Device, Vascular, For Promoting Embolization

ArtVentive Endoluminal Occlusion System (EOS)

ArtVentive Endoluminal Occlusion System (EOS), 7.5Fr Guide Catheter

Device, Vascular, For Promoting Embolization

Obsidio™

Conformable Embolic

Device, Vascular, For Promoting Embolization

Straight – 18

2 catalogue numbers from M0013120050, listed by Boston Scientific Corporation, United States, under Device, Vascular, For Promoting Embolization. 6 manufacturers in China are registered for this product code.

Device, Vascular, For Promoting Embolization

Complex Helical – 18

6 catalogue numbers from M0013120440, listed by Boston Scientific Corporation, United States, under Device, Vascular, For Promoting Embolization. 6 manufacturers in China are registered for this product code.

Device, Vascular, For Promoting Embolization

Device, Vascular, for Promoting Embolization

RMCS-2.75US Detachment Cable SET

Device, Vascular, For Promoting Embolization

Inzone

2 catalogue numbers from M00345100950, listed by Stryker GmbH, Switzerland, under Device, Vascular, For Promoting Embolization. 6 manufacturers in China are registered for this product code.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer