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Asante Solutions, Inc.

FDA Regulatory Profile

Summary

Total Recalls
8
510(k) Clearances
2
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0597-2014Class IIAsante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-packs, singles, or insidNovember 19, 2013
Z-0594-2014Class IIAsante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-packs, singles,or inside aNovember 19, 2013
Z-0598-2014Class IIAsante Conset Infusion Set with 60cm tubing & 6mm cannula packaged in 5-packs,singles,or inside a CoNovember 19, 2013
Z-0595-2014Class IIAsante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-packs, singles,or inside aNovember 19, 2013
Z-0596-2014Class IIAsante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-packs,singles, or inside November 19, 2013
Z-0601-2014Class IIAsante Conset Infusion Set with tubing & 9mm cannula packaged in 5-packs,singles,or inside a CombinaNovember 19, 2013
Z-0599-2014Class IIAsante Conset Infusion Set with 60cm tubing & 9mm cannula packaged in 5-packs,singles, or inside a CNovember 19, 2013
Z-0600-2014Class IIAsante Conset Infusion Set with 110cm tubing & 6mm cannula packaged in 5-packs, singles,or inside a November 19, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K142619Snap Insulin Pump SystemDecember 18, 2014
K122483PEARL DIABETES MANAGEMENT SYSTEMJanuary 3, 2013