510(k) K935601

0.22 MICRON FINAL FILTER WITH EXTENSION TUBE by Puritas Health Care, Inc. — Product Code FPA

K935601 is an FDA 510(k) premarket notification submitted by Puritas Health Care, Inc. for the device "0.22 MICRON FINAL FILTER WITH EXTENSION TUBE". The FDA issued a decision of Substantially Equivalent on January 21, 1994. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Puritas Health Care, Inc. has at least 10 other 510(k) clearances on record.