TRANSEND 300 ES GUIDEWIRE - 46-814

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

510(k) Number

K022357 ↗

FDA Product Code

DQX

Models / Variants

46-814

Transend 300 Floppy Guidewire

Model 46-815

Device Class

Class II

Regulation

21 CFR Part 870.1330

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Matrix Detachable Coils

  Class II

  FDA 510(k) K012985 Active Cleared 31 Jan 2002

• Gdc Stretch Resistant Detachable Coil

  Class II

  FDA 510(k) K030475 Active Cleared 14 Mar 2003

• In-Time Retrieval Device

  Class II

  FDA 510(k) K014109 Active Cleared 12 Mar 2002

• Guglielmi Detachable Coil (Gdc)

  Class II

  FDA 510(k) K031049 Active Cleared 1 Aug 2003

• Gdc Ultrasoft Coil

  Class II

  FDA 510(k) K002181 Active Cleared 11 Aug 2000

• Gdc-10 Guglielmi Detachable Coil (Gdc) (3D Shape Gdc), Gdc-18 Guglielmi Detachable Coil (Gdc) (3D Shape Gdc)

  Class II

  FDA 510(k) K993417 Active Cleared 21 Jan 2000

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• What is the primary difference between the Transend 300 ES Guidewire and the Transend 300 Floppy Guidewire in terms of clinical use?

  The Transend 300 ES Guidewire (Model 46-814) is designed with enhanced stiffness for better directional control, making it ideal for precise navigation in neuro and peripheral vasculature where controlled advancement is critical. In contrast, the Transend 300 Floppy Guidewire (Model 46-815) offers greater flexibility, which is beneficial for delicate vascular access or when navigating tortuous anatomy without requiring extension wires.

• Are these guidewires compatible with standard manual torque devices, and why might that matter?

  Yes, both the Transend 300 ES and Floppy Guidewires are compatible with standard manual torque devices. This compatibility is important because it allows clinicians to manipulate the guidewire effectively for directional control during procedures, ensuring smoother catheter exchange and navigation in complex vascular pathways.

• How should these guidewires be stored, and what does the single-use designation imply for clinical workflow?

  These guidewires are supplied sterile and must be stored following standard sterile medical device protocols to maintain integrity. The single-use designation implies they are not intended for reuse, which helps prevent cross-contamination and ensures consistent performance for each procedure, reducing the risk of complications associated with reprocessed devices.

• What are the key dimensions of these guidewires, and how do they support their intended use?

  Both guidewires have a uniform diameter of 0.014 inches and a length of 300 cm, which allows for precise navigation through both neuro and peripheral vasculature. The length eliminates the need for extension wires, while the diameter ensures compatibility with standard catheters and interventional tools, making them versatile for a range of clinical scenarios.

• What regulatory pathway was followed for these devices, and what does that mean for clinicians?

  The Transend 300 ES and Floppy Guidewires were cleared through the FDA’s 510(k) process (K022357) with a determination of substantial equivalence, reviewed by the Cardiovascular Advisory Committee. This means the devices were evaluated against a legally marketed predicate and deemed to have similar intended use and technological characteristics, providing clinicians with confidence in their safety and performance for neuro and peripheral vascular procedures.