Nucleus-X PTV Catheter
FDA 510(k)Class II (US FDA 510(k))
by NuMED, Inc.
Identifiers
- 510(k) Number
- DEN080015 FDA 510(k)
- FDA Product Code
- OZT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1255 FDA 510(k)
- Regulation Number
- 870.1255 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- DENG FDA 510(k)
This device is a balloon aortic valvuloplasty catheter. It is designed for percutaneous transluminal valvuloplasty (PTV) of the mitral and aortic valves.
The catheter features a braided inner tubing for increased pushability and a waist-formed balloon to facilitate seating in the valve annulus. It is supplied as a single-use device and is authorized under FDA 510(k) clearance (K080015) for cardiovascular use.
Frequently asked questions
What is the NUCLEUS-X PTV catheter used for?
The NUCLEUS-X PTV catheter is designed for percutaneous transluminal valvuloplasty (PTV) of the mitral and aortic valves, specifically as a balloon aortic valvuloplasty device to treat valve stenosis by dilating the valve opening.
Is the NUCLEUS-X PTV catheter supplied sterile and for single use only?
Yes, the NUCLEUS-X PTV catheter is supplied as a single-use device, meaning it is intended for one procedure only and should not be reprocessed or reused to ensure patient safety and device integrity.
What design features does the NUCLEUS-X PTV catheter have to improve performance during valvuloplasty?
The catheter features a braided inner tubing that increases pushability for better navigation through the vasculature and a waist-formed balloon that helps facilitate proper seating within the valve annulus during inflation.
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: NuCLEUS™ and NuCLEUS-X™ - NuMED For Children, NuCLEUS-X™ BAV and PTV Catheters - bisusa.com, NuCLEUS-X™ - NuMED For Children
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | DEN080015 | Class II | Active |
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Manufacturer
- Manufacturer
- NuMED, Inc.
Sources (1)
- FDA 510(k) DEN080015 24 fields · synced Sep 28, 2026