Vassallo GT 018 Floppy
by Filmecc Co., Ltd. 510(k)
Active
510(k) K213949
Overview
The Vassallo GT 018 Floppy is a steerable peripheral guide wire with a 0.018" diameter and available in 190cm or 300cm lengths. It features a solid stainless steel core, a hydrophilic-coated coil-type distal end, and a PTFE-coated shaft, designed to facilitate placement and exchange of diagnostic and therapeutic devices during intravascular procedures.
This device is supplied as a single-use product and is intended for cardiovascular applications. It received FDA 510(k) clearance with product code DQX on June 30, 2022, after being submitted on December 17, 2021, and classified as a Class 2 cardiovascular device under regulation 870.1330.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK213949 | Date30 Jun 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DQX
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1330
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Filmecc Co., Ltd.
Questions
What are the key features that make the Vassallo GT 018 Floppy guide wire suitable for cardiovascular procedures?
The Vassallo GT 018 Floppy guide wire is designed with a 0.018-inch diameter for precise navigation, a hydrophilic-coated distal end to enhance steerability and reduce friction, and a PTFE-coated shaft for smooth advancement. Its solid stainless steel core provides rigidity, while the 190cm or 300cm lengths accommodate varying procedural needs. These features collectively facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular interventions.
Is the Vassallo GT 018 Floppy guide wire intended for reuse, or is it meant to be used only once?
The Vassallo GT 018 Floppy guide wire is explicitly labeled as a single-use product, meaning it should not be reused after a single procedure. This classification aligns with best practices for maintaining sterility and reducing infection risks in medical settings.
What lengths are available for the Vassallo GT 018 Floppy guide wire, and how might this affect its use?
The Vassallo GT 018 Floppy guide wire is supplied in two lengths: 190cm and 300cm. The longer length (300cm) may be preferred for complex or longer procedures where additional reach is required, while the shorter length (190cm) could be suitable for more straightforward or shorter-access cases. The choice depends on the specific anatomy and procedural requirements.
How is the Vassallo GT 018 Floppy guide wire packaged and stored to ensure its integrity?
While the packaging details are not specified, the device is a single-use product, implying it is likely supplied in a sterile, sealed packaging to preserve its integrity until first use. Proper storage should follow manufacturer guidelines to avoid contamination or damage, such as keeping it in a clean, dry environment away from direct sunlight or extreme temperatures.
What regulatory pathway did the Vassallo GT 018 Floppy guide wire follow to gain market authorization in the U.S.?
The Vassallo GT 018 Floppy guide wire received FDA 510(k) clearance under the traditional review pathway, classified as a Class 2 cardiovascular device (regulation 870.1330). It was submitted on December 17, 2021, and granted clearance on June 30, 2022, with the product code DQX. This means it was determined to be substantially equivalent to a legally marketed predicate device.