DeviceClearance

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0) +6 more— 510(k) K233407

Substantially Equivalent

AtriCure, Inc.

FDA 510(k) clearance K233407 for AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0) +6 more, Substantially Equivalent on 2023-11-02. Applicant: AtriCure, Inc.. Device class: 2.

Clearance details

Device name as filed
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2); AtriClip PRO-V LAA Exclusion System (PROV); AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV)
Applicant
AtriCure, Inc.
Product code
Code PZX
Device class
Class 2
Regulation
21 CFR 878.4300
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Mason, OH, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code PZX

product code PZX
Death
6
Total
6

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.