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Pulmonx, Corp.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
5
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0235-2024Class IIZephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LPAugust 31, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K111764CHARTIS CONSOLENovember 10, 2011
K111522CHARTIS CATHETER MODEL CHR-CA-12.0September 29, 2011
K083199CHARTIS CONSOLEJune 25, 2009
K083883CHARTIS CATHETERJune 25, 2009
K973191THE VISUALIZED ENDOTRACHEAL TUBE SYSTEM OR VETT SYSTEMFebruary 13, 1998