Cardiovascular › Prosthetic

Which Manufacturers in China Work in This Section?

11 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Guangdong, Jiangsu and Beijing, and 2 other provinces. 2 of them are contract manufacturers. Chinese manufacturers are registered for 6 of 52 device types here.

1 of those 6 device types need no premarket submission before sale in the United States. The FDA has recorded 551 recalls across the section’s product codes; the root causes it names most often are Equipment maintenance (71), Process design (42) and Process control (42).

The Largest Device Types Made in China

The device types with the most Chinese manufacturers are Device, Vascular, For Promoting Embolization (6), Electrode, Pacemaker, Temporary (3), Agents, Embolic, For Treatment Of Uterine Fibroids (1), Analyzer, Pacemaker Generator Function (1) and Holder, Heart-Valve, Prosthesis (1). All 6 device types in this section with a Chinese manufacturer, most manufacturers first:

Device, Vascular, For Promoting Embolization 6 manufacturers
Electrode, Pacemaker, Temporary 3 manufacturers
Agents, Embolic, For Treatment Of Uterine Fibroids 1 manufacturer
Analyzer, Pacemaker Generator Function 1 manufacturer
Holder, Heart-Valve, Prosthesis 1 manufacturer
System, Balloon, Intra-Aortic And Control 1 manufacturer

Device, Vascular, For Promoting Embolization

Cerepak Uniform

CEREPAK UNIFORM XL Detachable Coil Delivery System Length - 190 cm Coil Diameter - 10 mm Coil Length - 17.1 cm

Device, Vascular, For Promoting Embolization

ConcertoTM

NV-10-30-HELIX Concerto Helix 10MMX30CM

Device, Vascular, For Promoting Embolization

Azur

The AZUR HydroPack 18 Peripheral Coil System is an implantable coil system intended to reduce or block blood flow in peripheral vessels. The filing describes use in interventional…

Electrode, Pacemaker, Temporary

MYO/Wire® Ultra-Thin Temporary Pacing Wires

MYO/Wire® Ultra-Thin Quadpolar - 150cm - White/Blue - Flare/Hook 4/10mm electrode

Device, Vascular, For Promoting Embolization

Axium™ Detachable Coil System

Coil QC-20-40-HELIX V05

Device, Vascular, For Promoting Embolization

Micrusframe

MICRUSFRAME S Microcoil 18 Stretch Resistant Coil and Detachable Coil System Contents: 1 Detachable Coil System Coil Type: MICRUSFRAME S 18 Stretch Resistant Coil 11mm (coil diameter) x…

System, Balloon, Intra-Aortic And Control

Linear 7.5fr. 25cc IAB (With APA) US Only

Catalogue number 0684-00-0478-02U, listed by Datascope Corp, United States, under System, Balloon, Intra-Aortic And Control. 1 manufacturer in China is registered for this product code.

Device, Vascular, For Promoting Embolization

Avenir Mega Coil System

35 catalogue numbers from 18HMG05020, listed by Shanghai Wallaby Medical Technologies Co., Inc., China, under Device, Vascular, For Promoting Embolization. 6 manufacturers in China are registered for this product code.

Device, Vascular, For Promoting Embolization

HydroFrame Framing Coil

93 catalogue numbers from 181546HFRM-V-A, 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

HydroSoft Advanced

66 catalogue numbers from 7210-0510, 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

Concerto Versa™

Concerto Versa is a detachable embolization coil for arteries and veins in the peripheral vasculature. A platinum-tungsten implant coil is attached to a composite delivery pusher for…

Device, Vascular, For Promoting Embolization

Optima Coil System

The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations (AVMs) and…

Device, Vascular, For Promoting Embolization

Tornado

Tornado Embolization Microcoil

Electrode, Pacemaker, Temporary

Detect®

Mapping Tool 10650 LES TST Detect 5P 18L

Device, Vascular, For Promoting Embolization

Galaxy G3

GALAXY G3 XSFT Microcoil Helical 12 Stretch Resistant Coil and Detachable Coil System Contents: 1 Detachable Coil System Coil Type: GALAXY G3 XSFT Helical 12 Stretch Resistant Coil 2mm…

Device, Vascular, For Promoting Embolization

MReye Flipper

MReye Flipper, Detachable Embolization Coil

Device, Vascular, For Promoting Embolization

Embosphere®

16 catalogue numbers from 00884450403464, 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

AxiumTM

APB-4-6-3D-SS Prime Bare Axium 4MMX6CM

Device, Vascular, For Promoting Embolization

Interlock™-35

Fibered IDC™ Occlusion System

Device, Vascular, For Promoting Embolization

Lobo

Peripheral Vascular Occluder

System, Balloon, Intra-Aortic And Control

CS100 Accessory Kit, English International (Aami), 110 V

Catalogue number 0020-00-0463-33, listed by Datascope Corp, United States, under System, Balloon, Intra-Aortic And Control. 1 manufacturer in China is registered for this product code.

Device, Vascular, For Promoting Embolization

Azur CX Detachable

34 catalogue numbers from 45-750511, 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

Polyvinyl Alcohol Embolic Microspheres

Canyon's Polyvinyl Alcohol Embolic Microspheres are nonresorbable particles used to obstruct selected vessels during embolization. Their compressible hydrogel structure is derived from…

Device, Vascular, For Promoting Embolization

Instant Detacher

Detacher ID-1-5 V02

Device, Vascular, For Promoting Embolization

Concerto

37 catalogue numbers from PV-14-30-HELIX, listed by Micro Therapeutics, Inc., United States, under Device, Vascular, For Promoting Embolization. 6 manufacturers in China are registered for this product code.

Device, Vascular, For Promoting Embolization

Avenir

Embolic Coil

Device, Vascular, For Promoting Embolization

MicroNester

Micro Nester Embolization Coil

Device, Vascular, For Promoting Embolization

Impede Embolization Plug

IMPEDE is an embolization plug for reducing or obstructing blood flow in peripheral vessels. It combines a self-expanding polyurethane-based foam plug with a distal helical anchor coil,…

Device, Vascular, For Promoting Embolization

HydroFill Helical

67 catalogue numbers from 101230HFIL-V-A, 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

V-Trak

MicroPlex HyperSoft Helical

Device, Vascular, For Promoting Embolization

Nester

Nester Embolization Microcoil

Device, Vascular, For Promoting Embolization

Ruby XL Coil System

Ruby Coil XL, 28mm x 55cm

Device, Vascular, For Promoting Embolization

HydroSoft Helical

80 catalogue numbers from 100608H2HS-V-A1, listed by MicroVention, Inc., United States, under Device, Vascular, For Promoting Embolization. 6 manufacturers in China are registered for this product code.

Electrode, Pacemaker, Temporary

TB

Temporary Pacing Lead Convenience Kit, 5F, Right Heart Curve Unshrouded

Device, Vascular, For Promoting Embolization

Concerto Detachable Coil System

Coil PV-14-30-HELIX V07

System, Balloon, Intra-Aortic And Control

Linear 7.5fr. 34cc IAB

Catalogue number 0684-00-0479-01, listed by Datascope Corp, United States, under System, Balloon, Intra-Aortic And Control. 1 manufacturer in China is registered for this product code.

Device, Vascular, For Promoting Embolization

Ultipaq

ULTIPAQ microcoil ULTIPAQ 10 Stretch Resistant Coil 2.5mm x 4cm 190cm Contents: 1 Detachable Coil System

System, Balloon, Intra-Aortic And Control

CS300 Accessory Kit, French, 220 V

Catalogue number 0020-00-0482-04, listed by Datascope Corp, United States, under System, Balloon, Intra-Aortic And Control. 1 manufacturer in China is registered for this product code.

Device, Vascular, For Promoting Embolization

Azur Pure Helical

36 catalogue numbers from 45-050706, 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

HyperSoft Advanced

56 catalogue numbers from 8510-0304, 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

HydroFrame 10 Advanced

104 catalogue numbers from 7110-0519, 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

MReye

MReye Embolization Coil

Device, Vascular, For Promoting Embolization

Concerto Versa™

Coil CV-18-40 Concerto Versa V02

System, Balloon, Intra-Aortic And Control

Arrow

Spring-Wire Guide for use with Standard 30 cc and 40 cc Intra-Aortic Balloon Catheters

Device, Vascular, For Promoting Embolization

Prestige Coil System

The Prestige Packing Coil consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil delivery…

Electrode, Pacemaker, Temporary

Steelex

Steelex Elec 3/0 (2) 60CM HRT17/GS65V

Device, Vascular, For Promoting Embolization

Ruby Coil

Ruby Extra Soft, 2x10

Device, Vascular, For Promoting Embolization

MicroPlex Helical Soft

56 catalogue numbers from 100406HC-S-V, listed by MicroVention, Inc., United States, under Device, Vascular, For Promoting Embolization. 6 manufacturers in China are registered for this product code.

System, Balloon, Intra-Aortic And Control

CS100 Intra-Aortic Balloon Pump, Spanish, 220v

Catalogue number 0998-00-3013-58, listed by Datascope Corp, United States, under System, Balloon, Intra-Aortic And Control. 1 manufacturer in China is registered for this product code.

Device, Vascular, For Promoting Embolization

Azur Detachable Helical HydroCoil

61 catalogue numbers from 45-481215, listed by MicroVention, Inc., United States, under Device, Vascular, For Promoting Embolization. 6 manufacturers in China are registered for this product code.

System, Balloon, Intra-Aortic And Control

Linear 7.5fr 40cc IAB With Accessories (APA) (Turkey)

Catalogue number 0684-00-0480-10, listed by Datascope Corp, United States, under System, Balloon, Intra-Aortic And Control. 1 manufacturer in China is registered for this product code.

Device, Vascular, For Promoting Embolization

MVP®

Vascular Plug MVP-7Q Mechanical 7MM V03

Device, Vascular, For Promoting Embolization

Complex 18 Advanced

28 catalogue numbers from 8118-0717-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

VFC Advanced

18 catalogue numbers from 8310-1540-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

Embozene®

20 catalogue numbers from 01-0301-02501-11, 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

HydroFrame 18 Advanced

29 catalogue numbers from 7118-1139, listed by MicroVention, Inc., United States, under Device, Vascular, For Promoting Embolization. 6 manufacturers in China are registered for this product code.

Agents, Embolic, For Treatment Of Uterine Fibroids

Embozene Microspheres (Opaque)

20 catalogue numbers from 19020-S0, listed by Celonova Biosciences, Inc., United States, under Agents, Embolic, For Treatment Of Uterine Fibroids. 1 manufacturer in China is registered for this product code.

Device, Vascular, For Promoting Embolization

Axium™ Prime Detachable Coil System

Coil APB 3.5-10 3D-ES V06

Device, Vascular, For Promoting Embolization

Orbit Galaxy Xtrasoft

ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=4mm 10cm Contents: 1 detachable coil system and 1 luer valve. Coil Type: Complex Xtrasoft Note: ONLY use…

System, Balloon, Intra-Aortic And Control

Mega 7.5fr 30cc IAB With Accessories (Turkey)

Catalogue number 0684-00-0294-09, listed by Datascope Corp, United States, under System, Balloon, Intra-Aortic And Control. 1 manufacturer in China is registered for this product code.

Electrode, Pacemaker, Temporary

Myo/Wire

Extended Length Temp Pacing Wire

Device, Vascular, For Promoting Embolization

Orbit Galaxy

ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=16mm 30cm Contents: 1 Detachable Coil System with Tight Distal Loop technology and 1 luer valve. Coil…

Device, Vascular, For Promoting Embolization

MicroPlex Cosmos

6 catalogue numbers from 181652CS-V, 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

HydroFill Advanced

58 catalogue numbers from 7310-0830-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

Cosmos 10 Advanced

32 catalogue numbers from 8210-0722-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

Axium PrimeTM

Coil APB-3.5-10-3D-ES V04

Device, Vascular, For Promoting Embolization

Target XL

22 catalogue numbers from M0036117200, listed by Stryker GmbH, Switzerland, under Device, Vascular, For Promoting Embolization. 6 manufacturers in China are registered for this product code.

Device, Vascular, For Promoting Embolization

Micrusphere

MICRUSPHERE XL microcoil MICRUSPHERE XL 18 Stretch Resistant Coil 11mm x 28cm 190cm Contents: 1 Detachable Coil System

Device, Vascular, For Promoting Embolization

Cashmere

CASHMERE microcoil CASHMERE 14 Stretch Resistant Coil 11mm x 27cm 190cm Contents: 1 Detachable Coil System

System, Balloon, Intra-Aortic And Control

CS100 Intra-Aortic Balloon Pump, Spanish, 110v

Catalogue number 0998-00-3013-57, listed by Datascope Corp, United States, under System, Balloon, Intra-Aortic And Control. 1 manufacturer in China is registered for this product code.

Device, Vascular, For Promoting Embolization

Azur Detachable Framing Coil

35 catalogue numbers from 45-680820, 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

MicroPlex Compass Complex

38 catalogue numbers from 100355CMSR-V-A, listed by MicroVention, Inc., United States, under Device, Vascular, For Promoting Embolization. 6 manufacturers in China are registered for this product code.

Holder, Heart-Valve, Prosthesis

Masters Series™

Replacement Holder/Rotators

Device, 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…

System, Balloon, Intra-Aortic And Control

Cable,low LEV Output,datascope

Catalogue number 0012-00-1589-02, listed by Datascope Corp, United States, under System, Balloon, Intra-Aortic And Control. 1 manufacturer in China is registered for this product code.

System, Balloon, Intra-Aortic And Control

Cable,low Level Output,philips

Catalogue number 0012-00-1589-03, listed by Datascope Corp, United States, under System, Balloon, Intra-Aortic And Control. 1 manufacturer in China is registered for this product code.

Agents, Embolic, For Treatment Of Uterine Fibroids

Embozene Microspheres (Color-Advanced)

20 catalogue numbers from 10720-S1, listed by Celonova Biosciences, Inc., United States, under Agents, Embolic, For Treatment Of Uterine Fibroids. 1 manufacturer in China is registered for this product code.

Holder, Heart-Valve, Prosthesis

Handle 7615XL Annuloplasty XL 26L CE

Electrode, Pacemaker, Temporary

Cardiovascular › Prosthetic

Which Manufacturers in China Work in This Section?

The Largest Device Types Made in China

Where China Actually Supplies