KardiFlex NC Coronary Dilatation Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K202578 FDA 510(k)
- FDA Product Code
- LOX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5100 FDA 510(k)
- Regulation Number
- 870.5100 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The KardiFlex NC Coronary Dilatation Catheter is a sterile, single-use, non-pyrogenic device designed for transluminal coronary angioplasty procedures. It is classified as a Class 2 cardiovascular device under product code LOX and is intended for percutaneous use in the cardiovascular system.
The device is supplied sterile and is indicated for single use only. It received FDA 510(k) clearance (K202578) on May 6, 2021, through the traditional pathway, and is substantially equivalent to a legally marketed predicate device. The catheter features a balloon configuration with one marker for 1.5mm diameter or two markers for 2.0-5.0mm diameters.
Frequently asked questions
What is the KardiFlex NC Coronary Dilatation Catheter used for?
It is a sterile, single-use device intended for transluminal coronary angioplasty procedures to treat cardiovascular conditions.
How is the device supplied and is it reusable?
The device is supplied sterile and is indicated for single use only; it is not designed for reuse.
What balloon diameters are available for this catheter?
The device features a balloon configuration with one marker for a 1.5mm diameter or two markers for 2.0mm to 5.0mm diameters.
What regulatory pathway was used for this device?
The device received FDA 510(k) clearance (K202578) on May 6, 2021, through the traditional pathway.
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: KardiFlex NC Coronary Dilatation Catheter (K202578) — FDA 510 (k ..., K202578 FDA 510(k) - KardiFlex NC Coronary Dilatation Catheter, KardiFlex NC Coronary Dilatation Catheter - BEUDAMED, PDF Medcaptain Life Science Co., Ltd. David Xia Official Correspondent
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202578 | Class II | Active |
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Manufacturer
- Manufacturer
- Medcaptain Life Science Co., Ltd.
Sources (1)
- FDA 510(k) K202578 24 fields · synced Sep 27, 2026