Brilliant

The puncture needle or an intravascular catheter incorporates a lumen, which provides a conduit for the insertion of the guide wire into the vascular system. The various types of guide…

Registry build 21.09.26

The puncture needle or an intravascular catheter incorporates a lumen, which provides a conduit for the insertion of the guide wire into the vascular system. The various types of guide wires, model dependent, are utilized as a guiding mechanism for the insertion of the introduction sheath into the vascular system. The guide wire contains a wire collimator, which assists in funneling the wire through the lumen of the puncture needle or the intravascular catheter and contains marking that are visible under fluoroscopy, which can determine the length of the guide wire within the vascular system. The sheath introducer provides a conduit for introducing other interventional devices, including guide wires and interventional catheters, into the vasculature. The main components of the sheath introducer assembly are a hydrophilic coated sheath introducer, hemostasis valve housing, and a side port with tubing connected to a 3-way stopcock/valve. The hydrophilic coated dilator is used to provide support and stability to the sheath introducer during deployment into the vascular system. The proximal end of the dilator includes a luer port and has a tapered, atraumatic distal tip. Both the sheath and dilator contain bismuth, making these devices visible under fluoroscopy.

13manufacturers in China registered for this device type
122catalogue numbers in this listing
3510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (5), Beijing (3), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DYB
Manufacturer City Province Registered as Device types
Mehow Innovative (Huizhou) Ltd. Huizhou Guangdong Contract manufacturer 11
Tianjin Demax Medical Technology Co., Ltd. Tianjin Tianjin Contract manufacturer 5
Steris Sterilization Technologies (Suzhou) Ltd Suzhou Jiangsu Contract manufacturer 44
Shanghai INT Medical Instruments Co., Ltd. Shanghai Shanghai Contract manufacturer 10
Lepu Medical Technology (Beijing) Co., Ltd. Beijing Beijing Manufacturer 7
Beijing Target Medical Technologies Inc. Beijing Beijing Contract manufacturer 7
Beijing Demax Medical Technology Co., Ltd. Beijing Beijing Manufacturer 5
Curatia Medical Limited Suzhou Jiangsu Specification developer 5
Tianjin Ethylene Oxide Sterilization Technology Co., Ltd. Tianjin Tianjin Contract manufacturer 4
Shanghai Microport EP Medtech Co., Ltd. Shanghai Shanghai Manufacturer 3
Becton Dickinson Medical Devices Co., Ltd. Suzhou Suzhou Jiangsu Contract manufacturer 2
Cardiocycle Medical(Suzhou) Co., Ltd. Suzhou Jiangsu Complaint-file establishment 1

Showing 12 of 13. All 13 manufacturers in China registered for Introducer, Catheter

Record

Regulatory record for Brilliant
Listed by Lepu Medical Technology (Beijing) Co., Ltd., China
FDA product code DYB
Device type Introducer, Catheter
Device class Class 2
Regulation 21 CFR 870.1340
Establishment Manufacturer
Record published 2026-04-15
Record revised 2024-03-20 (version 3)

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 Box of 5

Catalogue Numbers

Catalogue numbers for Brilliant
Catalogue number Size Status
CS041618 In distribution
RSC062421 In distribution
RSC071125 In distribution
CS061125 In distribution
RSC060725 In distribution
CS052425 In distribution
ACS062435 In distribution
ACS050721 In distribution
RSC071121 In distribution
CS051125 In distribution
RSC040725 In distribution
RSC060721A In distribution
CS071121 In distribution
ACS051121-II In distribution
CS071621 In distribution
CS050718 In distribution
CS061618 In distribution
ACS061635 In distribution
ACS041121-II In distribution
RSC071621 In distribution
RSC041125 In distribution
RSC052425 In distribution
CS062418 In distribution
ACS052421 In distribution
ACS062421 In distribution
ACS062421-II In distribution
RSC071621A In distribution
RSC042421 In distribution
RSC062425 In distribution
RSC041625 In distribution
RSC070721 In distribution
CS060718 In distribution
CS040718 In distribution
CS061118 In distribution
CS061121 In distribution
CS071125 In distribution
CS062425 In distribution
CS042421 In distribution
CS041625 In distribution
CS041125 In distribution
CS052418 In distribution
ACS052421-II In distribution
CS051618 In distribution
CS051625 In distribution
ACS060721 In distribution
ACS040721 In distribution
ACS071635 In distribution
CS060721 In distribution
CS042425 In distribution
RSC070725 In distribution
CS052421 In distribution
RSC050721 In distribution
ACS060735 In distribution
RSC061121 In distribution
CS062421 In distribution
RSC042425 In distribution
RSC041621 In distribution
RSC051621 In distribution
RSC040721A In distribution
RSC042421A In distribution
RSC051121 In distribution
ACS071121-II In distribution
CS051621 In distribution
RSC072425 In distribution
CS071118 In distribution
CS070718 In distribution
CS072418 In distribution
RSC050725 In distribution
ACS071135 In distribution
ACS040721-II In distribution
RSC052421 In distribution
RSC051625 In distribution
CS072425 In distribution
RSC070721A In distribution
RSC071625 In distribution
CS042418 In distribution
CS040721 In distribution
CS051121 In distribution
CS041118 In distribution
RSC041121A In distribution
RSC050721A In distribution
RSC062421A In distribution
RSC052421A In distribution
RSC041621A In distribution
RSC071121A In distribution
RSC040721 In distribution
RSC061621A In distribution
ACS042421-II In distribution
CS050721 In distribution
RSC061121A In distribution
CS041121 In distribution
CS060725 In distribution
ACS042421 In distribution
CS061621 In distribution
CS040725 In distribution
ACS060721-II In distribution
CS041621 In distribution
RSC060721 In distribution
CS070721 In distribution
RSC061125 In distribution
ACS072435 In distribution
ACS070721-II In distribution
CS071618 In distribution
ACS061135 In distribution
ACS050721-II In distribution
RSC051125 In distribution
RSC072421 In distribution
RSC051621A In distribution
CS050725 In distribution
RSC061625 In distribution
CS051118 In distribution
RSC061621 In distribution
ACS061121-II In distribution
CS071625 In distribution
CS072421 In distribution
CS061625 In distribution
RSC041121 In distribution
ACS070735 In distribution
ACS072421-II In distribution
CS070725 In distribution
RSC051121A In distribution
RSC072421A In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Demax Beijing Demax Medical Technology Co., Ltd. 2,841
Arrow Teleflex Medical LLC 1,036
Prelude IDeal™ Merit Medical Systems, Inc. 294
Fast-Cath™ St. Jude Medical 213
Flexor Cook Incorporated 182
Prelude Ease™ Merit Medical Systems, Inc. 176
Performer Cook Incorporated 174
VSI Teleflex Medical LLC 154
Peel-Away Cook Incorporated 153
OptiSeal™ Greatbatch Medical 127
Super Sheath Togo Medikit Co., Ltd. 122
Tearaway Introducer Set Galt Medical Corp. 96

Showing 12 of 439. All products under Introducer, Catheter

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K172331 2018-03-02
K172099 2017-10-05
K123475 2014-02-03

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