510(k) K120261

PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION SITE, PPS PI PRESSURE INJECTABLE SAFETY HUBER by Perouse Medical — Product Code FPA

K120261 is an FDA 510(k) premarket notification submitted by Perouse Medical for the device "PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION SITE, PPS PI PRESSURE INJECTABLE SAFETY HUBER". The FDA issued a decision of Substantially Equivalent on May 2, 2012. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Perouse Medical has at least 2 other 510(k) clearances on record.