Invasive Pressure Adapter Cable, ICU

Assy, Cable, Adapter, IP, ICU, LP35

Registry build 21.09.26
22manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
1recall

Who Else Makes It

Concentrated in Guangdong (18), Jiangsu (1), Zhejiang (1). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DSA
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77
Ningbo Xinwell Medical Technology Co., Ltd. Cixi Zhejiang Contract manufacturer 12
APK Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 6
ABA Medical Technology Co Ltd Guang Dong Guangdong Contract manufacturer 6
Beijing Rongrui Century Science Technology Co., Ltd. Beijing Beijing Contract manufacturer 4
Dongguan Rongrui-Century Science&Technology Co., Ltd. Dongguan Guangdong Contract manufacturer 4
Dongguan Ruibaolian Medical Science & Technology Co., Ltd. Dongguan Guangdong Contract manufacturer 4
Dongguan Kepler Special Cabling Company Limited Dongguan Guangdong Contract manufacturer 3
Palconn Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 2
Shenzhen Redy-MED Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 2
GE Medical Systems (China) Co., Ltd. Wuxi Jiangsu Contract manufacturer 57
Edan Instruments, Inc. Shenzhen Guangdong Contract manufacturer 56

Showing 12 of 22. All 22 manufacturers in China registered for Cable, Transducer And Electrode, Patient, (Including Connector)

Record

Regulatory record for Invasive Pressure Adapter Cable, ICU
Listed by Physio-Control, Inc., United States
FDA product code DSA
Device type Cable, Transducer And Electrode, Patient, (Including Connector)
Device class Class 2
Regulation 21 CFR 870.2900
Establishment Specification developer, Complaint-file establishment, Manufacturer
Record published 2024-06-20

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only

Catalogue Numbers

Catalogue numbers for Invasive Pressure Adapter Cable, ICU
Catalogue number Size Status
11230 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Unimed Unimed Medical Supplies Inc 5,928
AMC LifeSync Corporation 1,058
Fogg System Company, Inc. Fogg System Company, Inc. 693
Multi-Link™ AirLife Finland Oy 611
Cable, Transducer And Electrode, Patient, (Including Connector) ConMed Corporation 284
Maguire Maguire Enterprises, Inc. 193
MediChoice Owens & Minor Distribution, Inc. 160
Vermed Graphic Controls Acquisition Corporation 159
Vital Signs™ AirLife Finland Oy 136
Multi-Link™ Carefusion Finland 320 Oy 136
Med-link Shenzhen MED-Link Electronics Tech Co., Ltd. 129
Conmed ConMed Corporation 106

Showing 12 of 1,260. All products under Cable, Transducer And Electrode, Patient, (Including Connector)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K240156 2024-04-30

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated FDA class Root cause Reason Quantity
2025-01-21 Class II Labeling Change Control Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions 245 units

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.

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