Equinox Occlusion Balloon Catheter/System - (10mm Balloon, 4 & 13 Mm Tip), (15 …
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K001237 FDA 510(k)
- FDA Product Code
- MJN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4450 FDA 510(k)
- Regulation Number
- 870.4450 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Equinox Occlusion Balloon Catheter/System is a temporary intravascular occlusion catheter designed for selective vascular occlusion. It employs inflatable balloons of varying diameters (10mm, 15mm, and 20mm) to occlude blood flow within vessels, typically used in interventional cardiology procedures to isolate specific vascular segments or control bleeding.
The system is supplied as a sterile, single-use device and is intended for use in controlled clinical settings such as catheterization labs. It includes catheters with dual tip sizes (4mm and 13mm) for compatibility with different vascular access points. The device is classified as Class II under FDA regulations (870.4450) and holds an FDA 510(k) clearance (K001237) with a special review designation. Storage and handling must adhere to sterile medical device protocols.
Frequently asked questions
What are the primary uses of the Equinox Occlusion Balloon Catheter/System in clinical practice?
The Equinox Occlusion Balloon Catheter/System is designed for selective vascular occlusion during interventional cardiology procedures. It temporarily blocks blood flow in specific vessel segments to isolate areas for targeted interventions, such as controlling bleeding or isolating regions for precise treatment. This is particularly useful in catheterization labs where controlled vascular isolation is required.
Are the catheters reusable or intended for single-use only, and how should they be stored?
The Equinox Occlusion Balloon Catheter/System is explicitly supplied as a sterile, single-use device. To maintain sterility and compliance with medical device protocols, it must be stored in its original packaging until use, following standard sterile medical device handling guidelines.
What balloon sizes and tip configurations are available for the Equinox Occlusion Balloon Catheter/System?
The system offers three balloon sizes—10mm, 15mm, and 20mm—paired with two tip diameters: 4mm and 13mm. This combination allows compatibility with different vascular access points, ensuring flexibility for various procedural needs.
How is the regulatory pathway for this device structured, and what does that mean for clinicians?
The Equinox Occlusion Balloon Catheter/System holds an FDA 510(k) clearance (K001237) with a special review designation under the Cardiovascular advisory committee. This means it has been deemed substantially equivalent to a legally marketed predicate device and is classified as a Class II medical device under FDA regulations (870.4450). Clinicians can rely on its regulatory clearance as evidence of safety and performance for temporary intravascular occlusion.
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: Equinox Occlusion Balloon Catheter/System - (10mm Balloon, 4 & 13 Mm ..., PDF K001237 - Equinox Occlusion Balloon Catheter/System - (10mm Balloon, 4 ..., FDA 510 (k), K001237, EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM ..., www.accessdata.fda.gov
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K001237 | Class II | Active |
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Manufacturer
- Manufacturer
- Micro Therapeutics, Inc.
Sources (1)
- FDA 510(k) K001237 24 fields · synced Sep 19, 2026