AtriClip® FLEX-Mini™ LAA Exclusion System

FDA UDI

Class II (US FDA UDI)

by Atricure, Inc.

Identity

Trade Name: AtriClip® FLEX-Mini™ LAA Exclusion System FDA UDI
Generic Name: Ligation clip, metallic FDA UDI
Device Name: LAA Exclusion System, ACHM40 FDA UDI
Model / Reference: ACHM40 FDA UDI
Description: LAA Exclusion System, ACHM40 FDA UDI

Identifiers

Catalog Number: A001404 FDA UDI
Primary DI / UDI-DI: 10840143911781 FDA UDI
510(k) Number: K234125 FDA UDI
FDA Product Code: PZX FDA UDI
GMDN Term: Ligation clip, metallic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4300 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Length — 40 Millimeter FDA UDI

Category: Ligation clip, metallic

AtriClip® FLEX-Mini™ LAA Exclusion System by Atricure, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K234125 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Atricure, Inc.

Sources (1)

FDA UDI 1b5ce23f-f5ad-4c94-91f2-7feae2aa193d 38 fields · synced May 29, 2026