Abbott Electrophysiology

Abbott Electrophysiology holds 4 FDA 510(k) medical device clearances, first cleared 2016, most recent 2017, with 1 FDA device recall on record.

FDA recalls by Abbott Electrophysiology

Z-2478-2015 — FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F (2.84mm) Model number : USAR064060 Sterile, Rx only Cardiovascular: For use in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.Class III·Terminated·2015-08-12

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

Recent clearances by Abbott Electrophysiology

K171583 — RhythmView WorkstationCode DQK·2017-09-01
K163709 — FIRMap CatheterCode MTD·2017-02-28
K161240 — Rhythm View Workstation (non-streaming)Code DQK·2016-08-10
K153093 — FIRMap CatheterCode MTD·2016-04-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.

Top product codes for Abbott Electrophysiology

FDA recalls by Abbott Electrophysiology

Recent clearances by Abbott Electrophysiology