Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Left Atrial Appendage Clip, Implantable

FDA product code PZX · 10 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.4300
Review panel
CV
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2018-06-28 – 2026-06-26

Intended to occlude the left atrial appendage.

PZX 2023-11-02

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.

K number K233407

View details →
↑