Identifiers
- 510(k) Number
- K203540 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 Bridge Occlusion Balloon is a catheter designed for intravascular occlusion, temporarily blocking blood flow in cardiovascular procedures. It is classified as a Class II medical device and is intended for use in temporary occlusion during cardiovascular interventions.
The device is supplied as a single-use product and is not indicated for MRI environments. It is authorized under FDA 510K clearance with product code MJN and is regulated under 870.4450. The device is manufactured by Spectranetics Corporation and is available in various sizes as specified in the device specifications.
Frequently asked questions
What is the Bridge Occlusion Balloon used for?
The Bridge Occlusion Balloon is a catheter designed for intravascular occlusion, temporarily blocking blood flow in cardiovascular procedures. It is intended for use during cardiovascular interventions where temporary occlusion is required.
Is the Bridge Occlusion Balloon single-use or reusable?
The Bridge Occlusion Balloon is supplied as a single-use product and is not intended for reuse. Each device should be discarded after a single procedure to ensure patient safety and device performance.
What sizes and models of the Bridge Occlusion Balloon are available?
The Bridge Occlusion Balloon is available in various sizes as specified in the device specifications. The exact size options should be referenced in the product specifications provided by Spectranetics Corporation.
What is the regulatory status of the Bridge Occlusion Balloon?
The Bridge Occlusion Balloon is authorized under FDA 510K clearance with product code MJN and is regulated under 870.4450. It is classified as a Class II medical device and is not indicated for MRI environments.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K203540 | Class II | Active |
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Manufacturer
- Manufacturer
- Spectranetics Corporation
- FDA Applicant
- Spectranetics, Inc.
Sources (1)
- FDA 510(k) K203540 24 fields · synced Sep 21, 2026