SmartGUIDE Deflectable Hydrophilic Guidewire

No FDA recalls on record, checked 23 Oct 2026.

Generic Name

Neurovascular guidewire

Model / Ref / Catalog

ASM-0001, ASM-0001-1

Primary DI / UDI-DI

07649989542014 EUDAMED

07649989542021 GUDID

Basic UDI-DI

7649989542ASM-0001BD

510(k) Number

K222690 ↗

FDA Product Code

MOF, DQX

EMDN Code

C04030201 Interventional coronary and peripheral vascular guide wires, hydrophilic

GMDN Term

Neurovascular guidewire

Device Class

Class III EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 870.1330

Market of Registration

France

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

• What types of procedures is the SmartGUIDE deflectable hydrophilic guidewire designed to assist with in neurovascular settings?

  The SmartGUIDE deflectable hydrophilic guidewire is specifically designed for use in cardiovascular procedures within neurovascular pathways. Its deflectable tip and hydrophilic coating enhance navigability, making it particularly useful for precise catheter placement and interventions in complex vascular anatomies, such as those encountered in stroke treatment or neurointerventions.

• Is the SmartGUIDE guidewire intended for single-use or can it be reused after sterilization?

  The SmartGUIDE deflectable hydrophilic guidewire is supplied as a single-use, sterile product. This design ensures patient safety and maintains sterility, which is critical in controlled clinical settings like catheterization laboratories where such devices are used.

• How should the SmartGUIDE guidewire be stored to maintain its sterility and functionality?

  The device must be stored according to manufacturer guidelines to preserve sterility and performance. Since it is a single-use, sterile product, it should be kept in its original packaging until use, away from direct sunlight, extreme temperatures, and contamination. Proper storage conditions are essential to ensure the hydrophilic coating and deflectable tip remain effective.

• What regulatory pathways does the SmartGUIDE guidewire follow, and which committees were involved in its review?

  The SmartGUIDE guidewire was reviewed under the FDA’s 510(k) pathway and is classified as a Class II medical device. Its submission was evaluated by the Cardiovascular (CV) Advisory Committee and filed under the Neurovascular (NE) review panel, with a decision code of SESE (Substantially Equivalent). It also complies with the Medical Device Regulation (MDR) in the EU.

• Are there multiple sizes or models of the SmartGUIDE guidewire, or is it available in a single configuration?

  The provided data does not specify exact sizes or model variations of the SmartGUIDE guidewire, but it is categorized under OpenFDA’s neurovascular guidewire listings (with multiple registration numbers). For precise sizing or model details, refer to the manufacturer’s technical documentation or contact Artiria Medical SA directly, as these specifics are not explicitly outlined in the regulatory submission.