Saranas, Inc.

FDA Regulatory Profile

Saranas, Inc. appears in FDA public data with 1 recall, 2 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1684-2022, Class II) was initiated on August 10, 2022. Its most recent 510(k) clearance was granted on May 25, 2023.

Summary

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

Recent Recalls

NumberClassProductDate
Z-1684-2022Class IIEarly Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)August 10, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K230273Saranas Early Bird Bleed Monitoring SystemMay 25, 2023
DEN180021Early Bird Bleed Monitoring SystemMarch 1, 2019