FDA.reportPublic FDA data

RadAR Vascular Compression Device

Primary DI
10815614020088
Brand
RadAR Vascular Compression Device
Company
Semler Technologies, Inc.
Model
4160
Catalog number
140-0160-00
Device description
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.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DXCClamp, Vascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXCClamp, VascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142122000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142122000RADAR VASCULAR COMPRESSION DEVICEAdvanced Vascular Dynamics2014-12-04DXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20815614020085PackageGS125In Commercial Distribution
10815614020088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081561402008520815614020085
1081561402008810815614020088

GMDN Terms#

Term, Definition table
TermDefinition
Radial artery compression deviceA device intended to provide compression for haemostasis to the puncture site on a patient having undergone radial artery catheterization, and can be used as an alternative to direct hand pressure. It typically consists of one or more pad/strap(s), which may also have a compression/decompression knob and a time indicator; it may be applied so that it does not compress the ulna artery or block venous return. It is typically used following coronary angiography/ventriculography or percutaneous transluminal coronary angioplasty (PTCA). This is a single-use device.

Regulatory Flags#

DUNS number
042075700
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10815614020156mBrace Wrist Support with Hook4250140-0250-002022-11-17
10815614020163mBrace Wrist Support with Clip4275140-0275-002022-11-17
10815614020170Wrist Assist Wrist Support4300140-0300-002022-11-17
10815614020262FlexBoard Wrist Support4400140-0400-002022-11-17
10815614020347WristAssist4300M140-0300-00-M2022-11-17
10815614021092mBrace 4285 Wrist Support with Hook4285140-0285-002025-02-27
10815614021085mBrace 4280 Wrist Support4280140-0280-002024-02-01
10815614020125mBrace Wrist Support4200140-0200-002022-11-15
10815614021115Elevate ArmBoard Extender H8100-EXTH180-0100-EXTH2025-05-19
10815614021122Elevate ArmBoard Extender H 8100-EXTH-U180-0100-EXTH-U2025-05-19
10815614020002CompressAR Compass Hand-Held Vascular Compression Assist Device3000130-0000-012016-09-24
10815614020804StatGuard Hemostatic Patch3010-00480-3010-002019-08-07
10815614020811StatGuard Hemostatic Dressing, Small3020-10480-3020-102018-09-27
10815614020828StatGuard Hemostatic Dressing, Regular3020-20480-3020-202019-02-28
10815614020033ComfortPress Hand-Held Vascular Compression Assist Device3100-13130-0100-132016-09-24
10815614020071RadAR Vascular Compression Device4150140-0150-002016-09-24
10815614020095RadAR EasyClik Vascular Compression Device4180140-0180-002016-09-24
10815614020118RadAR EasyClik Vascular Compression Device4185140-0185-002019-12-10
10815614020354ClampEase P-Series DiscP-700150-2031-702016-09-24
10815614020378Zephyr Vascular Compression Device9100-00190-0100-002016-09-24

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Primary DI, Brand, Company table
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10193489727173Medline Industries, Inc.MEDLINE INDUSTRIES, INC.DXC2022-08-04
10195594150808CARDINAL HEALTHCardinal Health 200, LLCDXC2021-07-09
M20630300D-Stat® Clamp topical hemostat accessoryVascular Solutions, Inc.DXC2016-09-15
M20635240Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
M20635270Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
M20635290Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
M20635370Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
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