Roadrunner PC Wire Guide, Olcott Torque Device

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

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

• 4 recalls, same reason

  • Ongoing Z-1841-2022 FDA Class II ·initiated 16 Aug 2022
  • Ongoing Z-1839-2022 FDA Class II ·initiated 16 Aug 2022
  • Ongoing Z-1838-2022 FDA Class II ·initiated 16 Aug 2022
  • Ongoing Z-1840-2022 FDA Class II ·initiated 16 Aug 2022

  Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

• 4 recalls, same reason

  • Ongoing Z-1709-2022 FDA Class II ·initiated 19 Jul 2022
  • Ongoing Z-1708-2022 FDA Class II ·initiated 19 Jul 2022
  • Ongoing Z-1706-2022 FDA Class II ·initiated 19 Jul 2022
  • Ongoing Z-1707-2022 FDA Class II ·initiated 19 Jul 2022

  Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

Trade Name

Roadrunner® EUDAMED

Roadrunner GUDID

Generic Name

Peripheral vascular guidewire, manual

Model / Ref / Catalog

RSTF-18-270, RSTF-18-300, RSTF-18-180, RSTF-14-300, G07584, G07640, G07557, G08801

Primary DI / UDI-DI

00827002075849, 00827002076402, 00827002075573, 00827002088016

Basic UDI-DI

0827002CINC011-010_A2UV

510(k) Number

K182985 ↗

FDA Product Code

DQX

EMDN Code

C04020202 Peripheral vascular therapeutic guidewires, non-hydrophilic

GMDN Term

Peripheral vascular guidewire, manual

Device Class

Class IIa EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 870.1330

Market of Registration

Germany

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

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• What is the Roadrunner PC Wire Guide, Olcott Torque Device specifically designed for in medical procedures?

  The Roadrunner PC Wire Guide, Olcott Torque Device is designed for precise catheter positioning and exchange during diagnostic and interventional vascular procedures. Its nitinol core, hydrophilic coating, and flexible platinum tip enhance maneuverability and torque transmission, making it ideal for navigating complex vascular pathways.

• Is the Roadrunner PC Wire Guide, Olcott Torque Device intended for reuse, or is it meant to be used only once?

  The Roadrunner PC Wire Guide, Olcott Torque Device is explicitly intended for single-use only, as stated in its design and supply specifications. This ensures patient safety and sterility for each procedure.

• How is the Roadrunner PC Wire Guide, Olcott Torque Device supplied, and what does that mean for its handling?

  The device is supplied sterile, meaning it is pre-sterilized and packaged to maintain sterility until use. This allows clinicians to rely on its cleanliness for immediate procedural use without additional sterilization steps, reducing contamination risks.

• What regulatory pathway was followed for the FDA clearance of the Roadrunner PC Wire Guide, Olcott Torque Device?

  The Roadrunner PC Wire Guide, Olcott Torque Device received FDA clearance through a 510(k) submission, classified as Substantially Equivalent (SESE) under 21 CFR 870.1330 with product code DQX. The review was conducted by the Cardiovascular (CV) Advisory Committee and filed under traditional clearance, not a de novo or breakthrough pathway.

• What distinguishes the Olcott Torque Device variant from other wire guides in terms of procedural support?

  The Olcott Torque Device variant is specifically engineered to provide consistent torque transfer, which is critical for navigating tortuous or complex vascular anatomies during procedures. This feature supports clinicians in achieving precise catheter placement and exchange with greater control.