510(k) K131869

PTS-X SIZING BALLOON CATHETER by NuMED, Inc. — Product Code MJN

K131869 is an FDA 510(k) premarket notification submitted by NuMED, Inc. for the device "PTS-X SIZING BALLOON CATHETER". The FDA issued a decision of Substantially Equivalent on August 8, 2013. The device falls under product code MJN (Catheter, Intravascular Occluding, Temporary), a Class II device regulated under 21 CFR 870.4450. NuMED, Inc. has at least 10 other 510(k) clearances on record.