Type I Brilliant Introducer Kit, Type II Brilliant Introducer Kit, Type III Brilliant Introducer Kit, Type IV Brilliant

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

Brilliant™

Model / Reference

RSC series, With stainless steel guidewire, RSC061618-SS70, With Nitinol guidewire, RSC061621-NJ70-IN20-K-S, RSC040518-NJ45-IN20, RSC041118-SJ45-IN20, RSC050725-SS45, RSC071625-NW70-IN20, With Hydrophilic guidewire, RSC040721-HS45, RSC051125-HW45, RSC041118-SS45-IN20-K-S, RSC060718-NW45-IN20-K-S, RSC070725-HW45

Primary DI / UDI-DI

06941785232894, 06941785236502, 06941785228156, 06941785225339, 06941785224042, 06941785236090, 06941785229979, 06941785230289, 06936733739457, 06941785229801, 06941785230388

Basic UDI-DI

69367337LP0038MX, 69367337LP0039MZ, 69367337LP0040MJ

510(k) Number

K140768 ↗

FDA Product Code

DYB

EMDN Code

C01040280 Peripheral angiography devices - accessories not included in other classes

Device Class

Class IIa EUDAMED

Class II 510(k)

Regulation

21 CFR Part 870.1340

EU market of registration

Cyprus

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• What types of procedures is the Brilliant Introducer Kit designed for, and how does it help during these procedures?

  The Brilliant Introducer Kit is specifically designed for interventional cardiology and vascular procedures. It facilitates the introduction of guide wires, catheters, and other interventional accessories into blood vessels. The kit’s hydrophilic-coated sheath and dilator improve pushability, flexibility, and resistance to kinking or gap formation, which helps minimize vessel trauma and ensures smoother, more controlled vascular access during procedures.

• Are the Brilliant Introducer Kits single-use or reusable, and what does this mean for clinical workflow?

  The Brilliant Introducer Kits are supplied as sterile, single-use devices. This means each kit is intended for one-time use only, reducing the risk of contamination and cross-infection. Clinically, this simplifies workflow by eliminating the need for reprocessing and ensures consistent performance per procedure, as each kit is pre-sterilized and ready for immediate use.

• What are the key differences between the Type I, II, III, and IV Brilliant Introducer Kits?

  The Brilliant Introducer Kit comes in four types (I, II, III, IV), each designed with variations in sheath and dilator sizes to accommodate different patient anatomies or procedural needs. While the exact specifications for each type aren’t detailed here, all types share the same core features—hydrophilic-coated sheaths and dilators for improved flexibility, pushability, and resistance to kinking. The differences likely lie in dimensions or compatibility with specific guidewire or catheter sizes, allowing clinicians to select the appropriate type based on their procedure requirements.

• How should the Brilliant Introducer Kit be stored, and what precautions should be taken before use?

  Since the Brilliant Introducer Kit is sterile and single-use, it should be stored in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Before use, ensure the packaging remains intact and uncompromised to maintain sterility. If the kit is exposed to moisture, contamination, or damage, it should not be used, as this could compromise its safety and performance.

• What regulatory pathways does the Brilliant Introducer Kit follow, and what does this mean for its safety and compliance?

  The Brilliant Introducer Kit is authorized under both FDA 510(k) clearance (K140768) and complies with MDR (Medical Device Regulation) standards. The FDA 510(k) clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device, ensuring it meets U.S. safety and performance requirements. Compliance with MDR further confirms adherence to stringent European regulatory standards for medical devices, reinforcing its safety, quality, and suitability for clinical use.