Cuattro LLC

FDA Regulatory Profile

Cuattro LLC appears in FDA public data with 1 recall, 2 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1934-2020, Class II) was initiated on October 15, 2019. Its most recent 510(k) clearance was granted on October 6, 2016.

Summary

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

Recent Recalls

NumberClassProductDate
Z-1934-2020Class IICuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0October 15, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K161937CuattroDROctober 6, 2016
K093480CUATTRO UNOMDMarch 5, 2010