Apheresis Technologies, Inc.

FDA Regulatory Profile

Apheresis Technologies, Inc. appears in FDA public data with 1 recall, 2 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2149-2012, Class II) was initiated on July 9, 2012. Its most recent 510(k) clearance was granted on June 14, 1996.

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2149-2012Class IIPlasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesetsJuly 9, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K961137ATI PLASMA PUMP (PP-04)June 14, 1996
K926409PLASMA DISCARD BAGSMarch 2, 1993