Identifiers
- 510(k) Number
- K200324 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 Rx Microcatheter is a dual-lumen catheter designed for percutaneous coronary interventions (PCI). It features a rapid exchange (Rx) delivery lumen and an over-the-wire (OTW) lumen, enabling versatile use in dual guidewire procedures. The reinforced shaft and removable stylet enhance pushability, while its smallest market profile allows for deployment within a 6F guiding catheter.
This microcatheter is supplied sterile and intended for single-use. It has an effective length of 135 cm, with depth markings at 95 cm and 105 cm from the distal tip, and is compatible with 0.014" (0.36 mm) or smaller guide wires. The device holds FDA 510(k) clearance under the product code DQY, with a K-number of K200324, and is regulated under the Cardiovascular advisory committee classification.
Frequently asked questions
What types of guidewires is the NHancer Rx Dual Lumen Rx Microcatheter compatible with, and why is this important for my procedures?
The NHancer Rx is designed to work with 0.014" (0.36 mm) or smaller guidewires, which is critical for navigating complex coronary anatomies during percutaneous coronary interventions (PCI). This compatibility ensures flexibility in dual-guidewire techniques, allowing operators to use either a rapid exchange (Rx) or over-the-wire (OTW) approach depending on procedural needs. The dual-lumen design supports simultaneous or sequential use of two guidewires, which can be essential for bifurcation lesions or other challenging cases.
Is the NHancer Rx Microcatheter reusable, and if not, how should it be handled after use to maintain sterility and safety?
The NHancer Rx is explicitly intended for single-use only, as stated in its design and regulatory submission. After use, it should be discarded in accordance with medical device disposal protocols to prevent contamination or reuse. The device is supplied sterile, so any handling after opening must adhere to aseptic techniques to avoid compromising sterility before insertion. Reuse could compromise structural integrity, pushability, or sterility, posing risks to patients.
What is the smallest guiding catheter size required to deploy the NHancer Rx, and how does this affect its usability in tight vascular access?
The NHancer Rx has a smallest market profile compatible with a 6F guiding catheter, which is advantageous for patients with smaller or more delicate vascular access points. This minimizes trauma to the artery and reduces the risk of complications like dissection or spasm during insertion. The compact profile also allows for greater maneuverability in tortuous coronary arteries, making it suitable for a broader range of patients, including those with smaller femoral or radial arteries.
How does the dual-lumen design of the NHancer Rx benefit operators during complex PCI procedures, and what specific features support this?
The dual-lumen design enables versatile guidewire management during PCI, allowing operators to use either a rapid exchange (Rx) or over-the-wire (OTW) guidewire—critical for procedures requiring dual-guidewire techniques, such as bifurcation stenting or chronic total occlusion (CTO) interventions. The reinforced shaft improves pushability, reducing the risk of kinking or buckling during advancement, while the removable stylet enhances torque control and maneuverability. These features collectively improve procedural success in complex cases.
What depth markings are present on the NHancer Rx, and how might they assist during coronary interventions?
The NHancer Rx includes depth markings at 95 cm and 105 cm from the distal tip, which help operators gauge catheter depth relative to the coronary anatomy. These markings are particularly useful for precise lesion targeting, ensuring the catheter is positioned accurately without over-advancement into critical coronary segments. The 135 cm effective length also provides sufficient reach for most coronary interventions while maintaining flexibility for varied patient anatomies.
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 ..., IMDS Operations B.V. NRX1413518 NHancer Rx, NHancer Rx NRX1413518 The NHancer™Rx is a dual lumen… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200324 | Class II | Active |
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Manufacturer
- Manufacturer
- IMDS Operations B.V.
Sources (1)
- FDA 510(k) K200324 24 fields · synced Sep 18, 2026