Advanced Cardiovascular Balloon Dilata
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K842556 FDA 510(k)
- FDA Product Code
- LIT 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 Advanced Cardiovascular Balloon Dilata is a Catheter, Angioplasty, Peripheral, Transluminal, designed for the dilation of narrowed or obstructed blood vessels. This device is intended to restore blood flow by mechanically widening arterial passages, particularly in peripheral vascular disease or coronary artery stenosis. Its primary function aligns with transluminal angioplasty techniques, where controlled expansion of the balloon within the vessel lumen achieves therapeutic lumen diameter.
This device is supplied as a single-use, sterile catheter and is classified under FDA regulation 870.1250 as a Class II medical device. It is intended for use in controlled clinical settings, such as catheterization laboratories, and requires proper handling to maintain sterility. The device’s design and specifications are authorized under FDA 510(k) clearance (K842556), with a traditional review process through the Cardiovascular (CV) advisory committee. No MRI safety information is provided, and sizes or additional technical specifications are not detailed in the available data.
Frequently asked questions
What is the Balloon Dilata catheter designed to treat?
The Balloon Dilata catheter is specifically designed for transluminal angioplasty in peripheral vascular disease or coronary artery stenosis. It mechanically widens narrowed or obstructed blood vessels to restore proper blood flow through controlled expansion within the vessel lumen. This is achieved by inflating the balloon inside the affected artery, effectively increasing the lumen diameter and improving circulation.
Is the Balloon Dilata catheter reusable or single-use?
The Balloon Dilata catheter is intended for single-use only. This design ensures sterility and safety, as it is supplied sterile and meant to be used once in a controlled clinical setting, such as a catheterization laboratory. Reuse is not recommended to prevent contamination or compromise of device integrity.
Where and how should the Balloon Dilata catheter be stored?
The Balloon Dilata catheter should be stored in its original, sealed packaging to maintain sterility. It must be kept in a clean, dry environment, protected from direct sunlight, extreme temperatures, and physical damage. Always follow the manufacturer’s instructions for storage to ensure the device remains functional and safe for use.
What regulatory pathway does the Balloon Dilata catheter follow?
The Balloon Dilata catheter is classified as a Class II medical device under FDA regulation 870.1250. It received FDA 510(k) clearance (K842556) through a traditional review process, with input from the Cardiovascular (CV) advisory committee. This clearance confirms its substantial equivalence to a predicate device and ensures it meets regulatory standards for safety and effectiveness.
Can the Balloon Dilata catheter be used in patients with pacemakers or other implanted devices?
The available data does not provide explicit MRI safety information for the Balloon Dilata catheter. While it is primarily used in controlled clinical settings like catheterization labs, caution should be exercised when using it near electronic devices like pacemakers. Always consult the full device labeling and follow best practices to avoid interference or complications.
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: ADVANCED CARDIOVASCULAR BALLOON DILATA (K842556) — FDA 510(k) | Innolitics, K842556 FDA 510 (k) - ADVANCED CARDIOVASCULAR BALLOON DILATA, PDF K842556 - Advanced Cardiovascular Balloon Dilata, Adv Cardio Sys Dbl Lumen Balloon Dilata Catheter, Advanced Cardiovascular Systems 2026 Company Profile: Valuation ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K842556 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Advanced Cardiovascular Systems, Inc.
Sources (1)
- FDA 510(k) K842556 24 fields · synced Oct 1, 2026