AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove Section Guide Model Various LAA0
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K093679 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 is an implantable clip device designed for exclusion of the heart's left atrial appendage (LAA). It contains the Gillinov-Cosgrove LAA Clip, which is pre-loaded on a disposable clip applier and provided with a section guide for proper placement.
The system is supplied as a single-use, sterile, self-closing implantable clip preloaded on a single-use clip applier, along with a selection guide. It does not contain natural rubber latex components. The device received FDA 510(k) clearance (K093679) and is classified as a Class II implantable clip under regulation number 878.4300.
Frequently asked questions
What is the AtriClip LAA Exclusion System used for?
The AtriClip LAA Exclusion System is designed for exclusion of the heart's left atrial appendage (LAA), which helps prevent blood clots from forming in the LAA and reduces stroke risk in patients with atrial fibrillation.
How is the AtriClip LAA Exclusion System supplied and is it reusable?
The system is supplied as a single-use, sterile, self-closing implantable clip preloaded on a disposable clip applier, along with a selection guide; it is intended for one-time use only and must not be reused.
Does the AtriClip LAA Exclusion System contain natural rubber latex?
The device does not contain natural rubber latex components, making it suitable for patients with latex sensitivities or allergies.
What regulatory pathway was used for the AtriClip LAA Exclusion System?
The device received FDA 510(k) clearance under submission number K093679 and is classified as a Class II implantable clip under regulation number 878.4300.
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: PDF AtriClip® LAA Exclusion System with Preloaded Gillinov-Cosgrove® Clip, PDF AtriClip® LAA Exclusion System with preloaded Gillinov-Cosgrove® Clip ..., PDF AtriClip® LAA Exclusion System with Preloaded Gillinov-Cosgrove® Clip
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K093679 | Class II | Active |
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Manufacturer
- Manufacturer
- Atricure, Inc.
Sources (1)
- FDA 510(k) K093679 24 fields · synced Oct 1, 2026