Fustar Steerable Introducers
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K100184 FDA 510(k)
- FDA Product Code
- DQY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Fustar Steerable Introducers are a class of vascular sheaths designed for percutaneous interventional procedures. These devices facilitate controlled access within blood vessels to introduce therapeutic or diagnostic tools, such as occluders, balloons, filters, stents, catheters, or fluids for intervention.
Used in cardiovascular interventional settings, these introducers are intended for single-use applications and are supplied sterile. They are regulated under FDA 510(k) clearance (K100184) and comply with the Medical Device Directive (MDD). The product code assigned is DQY, and they are manufactured by Lifetech Scientific (Shenzhen) Co., Ltd.
Frequently asked questions
Are these introducers designed for reuse or single-use, and how does that affect their handling?
The Fustar Steerable Introducers are explicitly designed for single-use only. This means each device should be used once and then discarded to maintain sterility and safety. Since they are supplied sterile, reuse could compromise sterility and increase infection risks, so proper disposal after a single procedure is essential.
What types of interventional tools can be introduced through these vascular sheaths?
These introducers are engineered to facilitate the delivery of a variety of therapeutic and diagnostic tools, including occluders, balloons, filters, stents, catheters, and fluids used during cardiovascular interventions. Their design ensures controlled access within blood vessels for precise placement of these devices.
How should I store the Fustar Steerable Introducers before use, given they are sterile?
Since the introducers are supplied sterile, they should be stored in their original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging protects sterility, so avoid opening or handling the device until immediately before use to prevent contamination.
What regulatory pathways have these introducers followed, and which committee reviewed them?
The Fustar Steerable Introducers were cleared through the FDA’s 510(k) process (K100184) under the Cardiovascular (CV) Advisory Committee, with a decision dated February 14, 2011. They also comply with the Medical Device Directive (MDD). The product code assigned is DQY, indicating their classification in vascular sheaths for interventional procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Fustar Steerable Introducer - lifetechmed.com, FUSTAR STEERABLE INTRODUCERS 510(k) K100184 - FDA.report, FUSTAR STEERABLE INTRODUCERS (K100184) — FDA 510(k) | Innolitics, PDF Exhibit #5 510(k) Summary S s r - Food and Drug Administration
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K100184 | Class II | Active |
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Manufacturer
- Manufacturer
- Lifetech Scientific (Shenzhen) Co., Ltd.
Sources (2)
- FDA 510(k) K100184 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026