PEROUSE MEDICAL

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
3
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1891-2017Class IIDOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 018April 5, 2017
Z-0877-2015Class IISynthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasOctober 6, 2014
Z-0876-2015Class IIBard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during October 6, 2014
Z-2089-2014Class IIPerouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to createMay 10, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K122834POLYSITE IMPLANTABLE INFUSION PORTSDecember 11, 2013
K123035SEAL ONENovember 28, 2012
K120261PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION SITE, PPS PI PRESSURE INJECMay 2, 2012