← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

PZX — Left Atrial Appendage Clip, Implantable

Intended to occlude the left atrial appendage.

DEVICE CLASS
Class II
REGULATION
21 CFR 878.4300
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
CV
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
510k: 3
0
RECALL ENTRIES

Recent clearances

K254232Edwards Lifesciences · 510k2026-06-26
K252917Genesee Biomedical, Inc. · 510k2026-05-22
K243860AtriCure, Inc. · 510k2025-01-15

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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