Cordis SV Steerable Guidewire

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 on record, checked 24 Oct 2026.

Trade Name

Cordis SV Steerable Guidewire EUDAMED

Sv Wire GUDID

Generic Name

Cardiac/peripheral vascular guidewire, single-use

Model / Ref / Catalog

503-558X EUDAMED

503558X GUDID

Primary DI / UDI-DI

10705032056069

Basic UDI-DI

07050320000000000000063CR

510(k) Number

K963214 ↗

FDA Product Code

DQX

EMDN Code

C04020299 Peripheral vascular guidewires, therapeutical - other

GMDN Term

Cardiac/peripheral vascular guidewire, single-use

Device Class

Class IIa EUDAMED

Class II GUDID

Regulation Number

870.1330

Market of Registration

Ireland

Commercial Distribution

In Commercial Distribution

EUDAMED SRN

US-MF-000020031

Authorised representative

Cordis Cashel IE-AR-000017793

• INFINITI™ Diagnostic Catheter/SUPER TORQUE™ Diagnostic Catheter/SUPER TORQUE™ Plus Diagnostic Catheter/TEMPO™ AQUA Diagnostic Catheter

  Class III

  CE/MDR

• MYNX CONTROL™ Vascular Closure Device 5F

  Class III

  CE/MDR

• MYNX CONTROL™ Vascular Closure Device 6F/7F

  Class III

  CE/MDR

• AQUATRACK™ Hydrophilic Nitinol Guidewire C3515RSA

  Class II

  GUDID on market

• AQUATRACK™ Hydrophilic Nitinol Guidewire C3515RSS

  Class II

  GUDID on market

• AQUATRACK™ Hydrophilic Nitinol Guidewire C3515SSA

  Class II

  GUDID on market

See all devices from Cordis US Corp. →

• What types of vascular procedures is the Cordis SV Steerable Guidewire designed to assist with, and why is this important for clinicians?

  The Cordis SV Steerable Guidewire is specifically designed for coronary and peripheral vascular procedures, particularly in complex anatomies like tortuous vessels or challenging lesions. This makes it valuable for clinicians performing interventions where precise navigation and catheter placement are critical, such as angioplasty or stenting in difficult-to-reach areas.

• Is the Cordis SV Steerable Guidewire reusable, and if not, what does this mean for cost management in a clinical setting?

  No, the Cordis SV Steerable Guidewire is explicitly labeled as single-use only. This means each procedure requires a new guidewire, which helps ensure sterility and reduces the risk of cross-contamination. Clinically, this impacts inventory management and budgeting, as facilities must account for the cost of individual units rather than reusing them.

• What packaging and sterility details should clinicians consider when handling or storing this guidewire?

  The Cordis SV Steerable Guidewire is supplied sterile in sealed containers with reference codes **10705032056069** and **20705032056066**. Since it is non-reusable and sterile, clinicians must ensure the packaging remains intact until use and follow proper sterile technique during handling. Storage should comply with manufacturer guidelines to maintain sterility and functionality.

• Does the Cordis SV Steerable Guidewire contain any materials that could pose allergies or compatibility concerns for patients?

  The Cordis SV Steerable Guidewire is explicitly labeled as non-latex and does not contain animal or human tissues, endocrine disruptors, or medicinal products. This makes it suitable for patients with latex allergies or sensitivities to biological materials, reducing potential adverse reactions during use.

• How does the regulatory classification of this guidewire (Class IIa) influence its use in clinical settings?

  The Class IIa classification indicates this guidewire undergoes stricter regulatory oversight than Class I devices but is not as high-risk as Class III. Clinically, this means it has been evaluated for safety and performance through the FDA 510(k) and MDR processes, ensuring it meets established standards for steerable guidewires in coronary and peripheral vascular procedures. This classification also implies documented compliance with manufacturing and quality controls.