510(k) K201165

In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath by Coloplast Corp. — Product Code LJE

K201165 is an FDA 510(k) premarket notification submitted by Coloplast Corp. for the device "In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath". The FDA issued a decision of Substantially Equivalent (kit) on December 17, 2020. The device falls under product code LJE (Catheter, Nephrostomy), a Class U device. Coloplast Corp. has at least 10 other 510(k) clearances on record.