Abbott Electrophysiology

FDA Regulatory Profile

Abbott Electrophysiology appears in FDA public data with 1 recall, 4 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2478-2015, Class III) was initiated on August 12, 2015. Its most recent 510(k) clearance was granted on September 1, 2017.

Summary

Total Recalls
1
510(k) Clearances
4
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2478-2015Class IIIFIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F (2.84mm) Model nAugust 12, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K171583RhythmView WorkstationSeptember 1, 2017
K163709FIRMap CatheterFebruary 28, 2017
K161240Rhythm View Workstation (non-streaming)August 10, 2016
K153093FIRMap CatheterApril 7, 2016