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Nhancer

FDA 510(k)

Class II (US FDA 510(k))

510(k) K121077

by IMDS Operations B.V.

Identifiers

510(k) Number
K121077 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 NHancer Rx Dual Lumen Microcatheter is a dual-lumen, percutaneous catheter designed for coronary and peripheral vascular access. Its rapid-exchange (Rx) and over-the-wire (OTW) lumens enable simultaneous use of two guidewires, enhancing procedural versatility in complex interventions.

Supplied as a single-use device, the NHancer Rx features a reinforced shaft and a removable stylet for improved pushability. It is compatible with a 6 French guiding catheter and has received FDA 510(k) clearance (K121077) under the Traditional pathway, classified as a Class II Cardiovascular device (Product Code DQY).

Frequently asked questions

What types of procedures is the NHancer Rx Dual Lumen Microcatheter designed to assist with, and why does its dual-lumen design matter?

The NHancer Rx Dual Lumen Microcatheter is designed for coronary and peripheral vascular access procedures, particularly where procedural versatility is needed. Its dual-lumen design—featuring rapid-exchange (Rx) and over-the-wire (OTW) capabilities—allows simultaneous use of two guidewires. This enhances flexibility during complex interventions, such as those requiring multiple guidewire manipulations or simultaneous access for diagnostic or therapeutic tools.

Is the NHancer Rx Dual Lumen Microcatheter intended for reuse, or is it meant to be used only once?

The NHancer Rx Dual Lumen Microcatheter is explicitly supplied as a single-use device. This design choice ensures patient safety by preventing cross-contamination and maintaining sterility between procedures, which is critical in vascular interventions where infection risk must be minimized.

What guiding catheter size is compatible with the NHancer Rx, and how does this affect its clinical use?

The NHancer Rx is designed to be compatible with a 6 French guiding catheter, which is a standard size for many coronary and peripheral vascular procedures. This compatibility ensures smooth integration into existing workflows and procedural setups, allowing clinicians to leverage the microcatheter’s dual-lumen advantages within familiar catheter systems.

How does the reinforced shaft and removable stylet of the NHancer Rx improve its performance during procedures?

The reinforced shaft of the NHancer Rx enhances pushability, reducing friction and making it easier to navigate through tortuous or challenging vascular pathways. The removable stylet further improves maneuverability by allowing the catheter to be advanced independently once the stylet is removed, which is particularly useful in complex cases where precise placement is required.

What regulatory pathway was followed for FDA clearance of the NHancer Rx, and what does this classification mean for its use?

The NHancer Rx received FDA clearance under the Traditional 510(k) pathway (K121077) and is classified as a Class II Cardiovascular device (Product Code DQY). This classification means it is subject to general controls and special controls for cardiovascular devices, ensuring it meets performance standards for safety and effectiveness in coronary and peripheral vascular applications while requiring post-market surveillance.

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: NHancer Rx Dual Lumen Rx Microcatheter - IMDS - Interventional Medical ..., K200324 - NHancer Rx | FDA 510 (k) | Imds Operations B.V., PDF IMDS Operations B.V. Edwin Schulting CEO Ceintuurbaan Noord 150

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) K121077 24 fields · synced Sep 18, 2026