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

System, Balloon, Intra-Aortic And Control

Catheter Extender for 34 & 40cc IAB’s

Catalogue number 0684-00-0186, 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

CS300 Intra-Aortic Balloon Pump – UTS, Spanish, 110v

Catalogue number 0998-00-3023-87, 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

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.

System, Balloon, Intra-Aortic And Control

Mega 8fr. 50cc IAB

Catalogue number 0684-00-0498-01, listed by Datascope Corp, United States, under System, Balloon, Intra-Aortic And Control. 1 manufacturer in China is registered for this product code.

Analyzer, Pacemaker Generator Function

SigmaPace 1000

External Pacemaker Analyzer

System, Balloon, Intra-Aortic And Control

Mega 7.5fr. 40cc IAB With Accessories, US Only

Catalogue number 0684-00-0295-01U, 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

Zucker™ Temporary Pacing Electrode Catheter

Zucker Temporary Pacing Electrode Catheter, Bipolar, Platinum Electrodes

System, Balloon, Intra-Aortic And Control

CS300 Accessory Kit, English International (Aami), 110 V

Catalogue number 0020-00-0482-33, 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

Ruby

Ruby Standard, 20mm x 60cm

Agents, Embolic, For Treatment Of Uterine Fibroids

Bead Block™

Catalogue number EB2S507-US, listed by Boston Scientific Corporation, United States, under Agents, Embolic, For Treatment Of Uterine Fibroids. 1 manufacturer in China is registered for this product code.

System, Balloon, Intra-Aortic And Control

CS100 Accessory Kit, Swedish, 220 V

Catalogue number 0020-00-0463-09, 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 Color Advance 100um Embozene 1ml Colored – US

Catalogue number 11010-S1, listed by Varian Medical Systems, Inc, United States, under Agents, Embolic, For Treatment Of Uterine Fibroids. 1 manufacturer in China is registered for this product code.

System, Balloon, Intra-Aortic And Control

CS300 Accessory Kit, German, 220v

Catalogue number 0020-00-0482-03, 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

Catheter Extender for Yamato Plus IABs – 10 Pack

Catalogue number 0684-00-0195, 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

Assy CRM French

Catalogue number 0997-00-0986-04, 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,ecg LEAD,OR,5L,AAMI

Catalogue number 0012-00-1814-01, listed by Datascope Corp, United States, under System, Balloon, Intra-Aortic And Control. 1 manufacturer in China is registered for this product code.

Holder, Heart-Valve, Prosthesis

1141m Mitris Resilia Mitral Valve Handle

Stainless Steel Reusable Handle FOR Mitris

System, Balloon, Intra-Aortic And Control

Ultra Iabp Catheter Kit

The Insightra Intra Aortic Balloon Catheter Kit is used in conjunction with an intra-aortic balloon pumping circuit for the emergency treatment of patients in cardiogenic shock. This…

System, Balloon, Intra-Aortic And Control

AC PWR Cord,nema 5-15p Type B

Catalogue number 0012-00-1823-01, 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

Sensation 7fr. 34cc IAB (India)

Catalogue number 0684-00-0469-07, 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

Arrow

Temporary Pacing Catheter with Shrouded Pins/Introducer Kit

System, Balloon, Intra-Aortic And Control

CS300 Intra-Aortic Balloon Pump – UTS, Portuguese, 220v

Catalogue number 0998-00-3023-98, 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

Linear 7.5fr. 25cc IAB (India)

Catalogue number 0684-00-0478-07, 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

Linear 7.5fr 34cc IAB With Accessories (Turkey)

Catalogue number 0684-00-0479-09, 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,external Signal,iabp

Catalogue number 0012-00-0323, 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

CS300 Intra-Aortic Balloon Pump – UTS, Chinese, 220v

Catalogue number 0998-00-3023-75, 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

CS300 Intra-Aortic Balloon Pump, Refurbished, Portuguese,non-Uts,intl

2 catalogue numbers from 0998-UC-3023-68, listed by Datascope Corp, United States, under System, Balloon, Intra-Aortic And Control. 1 manufacturer in China is registered for this product code.

Holder, Heart-Valve, Prosthesis

Heart Valve Handle Accessory

Hdle,mitral ST/Steel F/USE W/ 6625 OR 9120R Heart VLV

System, Balloon, Intra-Aortic And Control

CS100 Accessory Kit, Spanish, 110v

Catalogue number 0020-00-0463-17, listed by Datascope Corp, United States, under System, Balloon, Intra-Aortic And Control. 1 manufacturer in China is registered for this product code.

Analyzer, Pacemaker Generator Function

External Pacemaker Ananlyzer

The EXPMT 2000 will test and verify all the functions of any External Pacemaker including, transcutaneous and Atrial and Ventricular sequential pacemakers. Operation of the analyzer is menu…

System, Balloon, Intra-Aortic And Control

Sensation Plus 8fr. 50cc IAB (W/O Statlock)

Catalogue number 0684-00-0576-03, 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

Myler™ Temporary Pacing Electrode Catheter

Myler Temporary Pacing Electrode Catheter, Bipolar, Platinum Electrodes

System, Balloon, Intra-Aortic And Control

Sensation 7fr 40cc IAB With Accessories (Turkey)

Catalogue number 0684-00-0470-09, 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

Linear 7.5fr. 40cc IAB With Accessories, US Only

Catalogue number 0684-00-0480-01U, 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

CS100 Intra-Aortic Balloon Pump, Refurbished, Spanish,non-Uts,intl

2 catalogue numbers from 0998-UC-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.

Holder, Heart-Valve, Prosthesis

Heart Valve Accessor

Handle,f/USE W/C-E Physio Ring Model 4450 N/S

System, Balloon, Intra-Aortic And Control

CS100 Intra-Aortic Balloon Pump, English, 220v

Catalogue number 0998-00-3013-55, listed by Datascope Corp, United States, under System, Balloon, Intra-Aortic And Control. 1 manufacturer in China is registered for this product code.

Holder, Heart-Valve, Prosthesis

SJM Regent™

Catalogue number Mechanical Heart Valve, listed by St. Jude Medical, United States, under Holder, Heart-Valve, Prosthesis. 1 manufacturer in China is registered for this product code.

System, Balloon, Intra-Aortic And Control

CS300 Intra-Aortic Balloon Pump, Refurbished, Spanish,uts,intl

CS300 Intra-Aortic Balloon Pump, Refurbished, SPANISH,NON-UTS,INT'L

System, Balloon, Intra-Aortic And Control

Linear 7.5fr. 34cc IAB (With APA) (China)

Catalogue number 0684-00-0479-02C, 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

CS300 Accessory Kit, French, 110 V

Catalogue number 0020-00-0482-16, listed by Datascope Corp, United States, under System, Balloon, Intra-Aortic And Control. 1 manufacturer in China is registered for this product code.

Holder, Heart-Valve, Prosthesis

Open Pivot™

Accy 581 Mitral Screw-ON Rotator SET 26L

System, Balloon, Intra-Aortic And Control

CS300 Accessory Kit, Portuguese, 110 V

Catalogue number 0020-00-0482-18, 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

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.

System, Balloon, Intra-Aortic And Control

Mega 7.5fr. 30cc IAB With Accessories (APA), US Only

Catalogue number 0684-00-0294-02U, 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

CS300 Intra-Aortic Balloon Pump, French, 220v

Catalogue number 0998-00-3023-64, 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

Assy,safety Disk,english

Catalogue number 0997-00-0985-01, 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

CS100 UTS Intra-Aortic Balloon Pump Italian 220v

Catalogue number 0998-00-3013-97, 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

Linear 7.5fr. 25cc IAB (INDIA)(With APA)

Catalogue number 0684-00-0478-08, 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 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

System, Balloon, Intra-Aortic And Control

CS300 Intra-Aortic Balloon Pump- UTS, Spanish, 220v

Catalogue number 0998-00-3023-88, 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

Sensation 7fr. 40cc IAB With Accessories, US Only

Catalogue number 0684-00-0470-01U, 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 Color Advance 1300um Embozene 1ml Colored – US

Catalogue number 113010-S1, listed by Varian Medical Systems, Inc, United States, under Agents, Embolic, For Treatment Of Uterine Fibroids. 1 manufacturer in China is registered for this product code.

System, Balloon, Intra-Aortic And Control

Cardiosave Battery Pack, LI-ION

Catalogue number 0146-00-0097, 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

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.

System, Balloon, Intra-Aortic And Control

CS300 Accessory Kit, Chinese, 220 V

Catalogue number 0020-00-0482-15, 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

CS300 Intra-Aortic Balloon Pump, German, 220v

Catalogue number 0998-00-3023-61, 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

Mega 7.5fr. 30cc IAB

Catalogue number 0684-00-0294-01, listed by Datascope Corp, United States, under System, Balloon, Intra-Aortic And Control. 1 manufacturer in China is registered for this product code.

Holder, Heart-Valve, Prosthesis

Valve Handle 7420

Handle 7420 VLV Hndle 234MM CEM Global

System, Balloon, Intra-Aortic And Control

Catheter Extenders for 50cc IAB’s

Catalogue number 0684-00-0526, 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

MicroPearl

Bland Beads

Electrode, Pacemaker, Temporary

Tempo Temporary Pacing Lead

The BioTrace Medical Tempo Temporary Pacing Lead is designed for temporary intracardiac pacing. The lead provides access to the right ventricle via either the femoral vein, subclavian vein…

System, Balloon, Intra-Aortic And Control

Cardiosave Hybrid Type J Plug

Catalogue number 0998-00-0800-32, 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 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.

Agents, Embolic, For Treatment Of Uterine Fibroids

Embozene Color Advance 250um Embozene 1ml Colored – US

Catalogue number 12010-S1, listed by Varian Medical Systems, Inc, United States, under Agents, Embolic, For Treatment Of Uterine Fibroids. 1 manufacturer in China is registered for this product code.

System, Balloon, Intra-Aortic And Control

Sensation 7fr. 40cc IAB

Catalogue number 0684-00-0470-01, 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

CS100 Intra-Aortic Balloon Pump, Chinese, 220v

Catalogue number 0998-00-3013-45, 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

Deltaplush

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

System, Balloon, Intra-Aortic And Control

Cardiosave Accessory Kit, Aami

Catalogue number 0020-00-0480-01, 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

Sensation Plus 7.5fr. 40cc IAB W/ Accessories (W/O Statlock)(China)

Catalogue number 0684-00-0568-05, 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

Cardiosave Accessory Kit, IEC

Catalogue number 0020-00-0480-02, 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

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.

Agents, Embolic, For Treatment Of Uterine Fibroids

Embozene Color Advance 250um Embozene 2ml Colored – US

Catalogue number 12020-S1, listed by Varian Medical Systems, Inc, United States, under Agents, Embolic, For Treatment Of Uterine Fibroids. 1 manufacturer in China is registered for this product code.

Electrode, Pacemaker, Temporary

Cable 5833SL SURGICAL5PK Disp SM 12FT US

System, Balloon, Intra-Aortic And Control

Cardiovascular › Prosthetic

Which Manufacturers in China Work in This Section?

The Largest Device Types Made in China

Where China Actually Supplies