RanD S.r.l.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
4
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2049-2021Class IICh24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, RefeApril 30, 2021
Z-2048-2021Class IIHang&Go (kit for hyperthermic perfusion), Reference Code R9900120April 30, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K161613Hang&Go PACDecember 28, 2016
K120026PERFORMER HT/ HANG&GO HT BASICMay 8, 2012
K070213PERFORMER CBP SYSTEMMarch 21, 2007
K052555MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPBMarch 15, 2006