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AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0) +6 m…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K233407

by Atricure, Inc.

Identifiers

510(k) Number
K233407 FDA 510(k)
FDA Product Code
PZX FDA 510(k)
Models / Variants
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0) FDA 510(k)
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1) FDA 510(k)
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2) FDA 510(k)
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO1) FDA 510(k)
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2) FDA 510(k)
AtriClip PRO-V LAA Exclusion System (PROV) FDA 510(k)
AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV) 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)

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0) +6 m… by Atricure, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 7 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Atricure, Inc.

Sources (1)

  • FDA 510(k) K233407 24 fields · synced Jun 18, 2026