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Micro Rx

FDA 510(k)

Class II (US FDA 510(k))

510(k) K223728

by IMDS Operations B.V.

Identifiers

510(k) Number
K223728 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 Micro Rx Rapid Exchange Microcatheter is a catheter, percutaneous designed for guidewire support during percutaneous coronary interventions (PCI). It provides enhanced stability for guidewire navigation through coronary and peripheral vasculature, facilitating precise catheter placement. Its rapid exchange system allows seamless integration with guide extension catheters (GECs) without requiring microcatheter removal, improving procedural efficiency. The device features a hydrophilic coating to reduce friction and improve maneuverability within blood vessels.

This microcatheter is supplied sterile and intended for single-use applications in interventional cardiology settings. It is compatible with standard guidewire sizes, including 0.014-inch, and is intended for use in MRI-unsafe environments. The device is authorised under FDA 510K clearance (K223728) and falls under predicate device K182570 (Venture 0.014

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: Micro Rx Rapid Exchange Microcatheter - IMDS, PDF IMDS Operations B.V. Edwin Schulting CEO Ceintuurbaan Noord 150, PDF Micro Rx, IMDS Operations B.V. RX135 Micro Rx - RevMed

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
IMDS Operations B.V.

Sources (1)

  • FDA 510(k) K223728 24 fields · synced Sep 20, 2026