RadAR Vascular Compression Device

The RadAR Vascular Compression Device Model 4160 provides economical, safe hemostasis for your post-catheterization radial access patients. The user can quickly make compression…

Registry build 21.09.26

The RadAR Vascular Compression Device Model 4160 provides economical, safe hemostasis for your post-catheterization radial access patients. The user can quickly make compression adjustements to permit patent blood flow through the artery and gradually release pressure during hemostasis, without unfastening the device. This enables patent hemostatsis which has been shown to reduce the incidence of chronic radial artery occlusion. The Model 4160 is natural in color.

10manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance

Who Else Makes It

Concentrated in Beijing (3), Zhejiang (2), Guangdong (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DXC
Manufacturer City Province Registered as Device types
Suzhou Meccan Import and Export Corp. Suzhou Jiangsu Contract manufacturer 71
Shanghai INT Medical Instruments Co., Ltd. Shanghai Shanghai Contract manufacturer 10
Tianjin Demax Medical Technology Co., Ltd. Tianjin Tianjin Contract manufacturer 5
Wickimed (Huizhou) Medical Equipment Manufacturing Co., Ltd. Huizhou Guangdong Contract manufacturer 3
Joykey Industrial (Pinghu) Limited Pinghu Zhejiang Contract manufacturer 43
Sunny Medical Device (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 11
Lepu Medical Technology (Beijing) Co., Ltd. Beijing Beijing Manufacturer 7
Terumo Medical Products (Hangzhou) Co., Ltd. Hangzhou Zhejiang Contract manufacturer 7
Beijing Target Medical Technologies Inc. Beijing Beijing Contract manufacturer 7
Beijing Demax Medical Technology Co., Ltd. Beijing Beijing Manufacturer 5

Record

Regulatory record for RadAR Vascular Compression Device
Listed by Semler Technologies, Inc., United States
FDA product code DXC
Device type Clamp, Vascular
Device class Class 2
Regulation 21 CFR 870.4450
510(k) K142122
Record published 2016-09-24
Record revised 2024-10-16 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Packaging Case of 25, case of 50

Catalogue Numbers

Catalogue numbers for RadAR Vascular Compression Device
Catalogue number Size Status
4160 In distribution
4150 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Millennium Avalign Technologies, Inc. 831
Novo Surgical Novo Surgical, Inc. 708
Ambler Surgical Ambler Surgical, LLC 575
Pilling Teleflex Medical LLC 544
Avalign Avalign Technologies, Inc. 543
Boss Instruments Boss Instruments, Ltd. 457
V. Mueller Steris Corporation 432
Wexler Surgical, Inc. Wexler Surgical, Inc. 342
Integra® Jarit® Integra LifeSciences Production Corporation 331
Scanlan® Scanlan International, Inc. 294
HNM Medical HNM Stainless, LLC. 230
Aesculap Aesculap AG 136

Showing 12 of 639. All products under Clamp, Vascular

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K002767 2000-09-27

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