AtriClip LAA Exclusion System with Preloaded PRO·V Clip
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K173031 FDA 510(k)
- FDA Product Code
- FZP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4300 FDA 510(k)
- Regulation Number
- 878.4300 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The AtriClip LAA Exclusion System with Preloaded PRO·V Clip is an implantable clip designed for the occlusion of the left atrial appendage (LAA). This device is intended to electrically isolate the LAA from the left atrium, reducing the risk of thromboembolic events by preventing blood flow through the appendage. It is classified as a Class II medical device under FDA regulations and is intended for use during cardiac surgical procedures requiring direct visualization of the heart.
The system is supplied sterile and for single-use, featuring a preloaded PRO·V Clip for ease of deployment. It is intended for use in an operating room setting and requires direct visualization of the LAA. The device is non-absorbable and is regulated under FDA 510(k) clearance (K173031) with a special review classification. No additional regulatory markings or MRI safety information are specified in the provided data.
Frequently asked questions
What is the AtriClip LAA Exclusion System with Preloaded PRO·V Clip primarily used for in a clinical setting?
The AtriClip LAA Exclusion System with Preloaded PRO·V Clip is designed for the occlusion of the left atrial appendage (LAA) during cardiac surgical procedures requiring direct visualization of the heart. Its purpose is to electrically isolate the LAA from the left atrium, which helps reduce the risk of thromboembolic events by preventing blood flow through the appendage.
Is the AtriClip LAA Exclusion System with Preloaded PRO·V Clip intended for single-use or reusable applications?
The AtriClip LAA Exclusion System with Preloaded PRO·V Clip is explicitly supplied sterile and intended for single-use only. This ensures patient safety and sterility during surgical procedures.
Where and how is the AtriClip LAA Exclusion System with Preloaded PRO·V Clip typically deployed?
The device is intended for use in an operating room setting and requires direct visualization of the left atrial appendage (LAA). It is deployed during cardiac surgical procedures where the heart is directly accessible.
What regulatory pathway does the AtriClip LAA Exclusion System with Preloaded PRO·V Clip follow in the U.S.?
The AtriClip LAA Exclusion System with Preloaded PRO·V Clip follows the FDA 510(k) clearance pathway, specifically classified as a Class II medical device with a special review designation. It holds a clearance number (K173031) and is intended for use under the FDA’s regulatory framework.
Does the AtriClip LAA Exclusion System with Preloaded PRO·V Clip come preloaded with a clip, and what does this mean for ease of use?
Yes, the AtriClip LAA Exclusion System comes preloaded with the PRO·V Clip, which simplifies deployment during surgery. This feature reduces handling time and potential contamination risks, as the clip is ready for immediate use once the system is opened.
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: AtriClip LAA Exclusion System - AtriCure, Inc., AtriClip PRO-V Device | LAA Exclusion System | AtriCure, AtriClip LAA Exclusion System with Preloaded PRO·V Clip (K173031) — FDA ..., AtriClip LAA Exclusion System - AtriCure, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K173031 | Class II | Active |
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Manufacturer
- Manufacturer
- Atricure, Inc.
Sources (1)
- FDA 510(k) K173031 24 fields · synced Sep 19, 2026