Abbott Electrophysiology
Country not established
- Devices
- 4
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Abbott Electrophysiology makes
Abbott Electrophysiology manufactures electrophysiology (EP) mapping systems, including the RhythmView Workstation and FIRMap Catheter, designed for cardiac arrhythmia diagnosis and ablation procedures. These tools provide real-time mapping and radiofrequency ablation guidance to support treatment of atrial fibrillation and other complex arrhythmias.
The company’s devices are classified as Class II under FDA regulations and are authorised via 510(k) clearance. The portfolio is listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
RhythmView Workstation Ref K171583
Regimes: 510(k) Registry: 510(k)FIRMap Catheter Ref K163709
Regimes: 510(k) Registry: 510(k)Rhythm View Workstation (non-streaming) Ref K161240
Regimes: 510(k) Registry: 510(k)FIRMap Catheter Ref K153093
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Abbott Electrophysiology, initiated on 2015-08-12. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2015
- 12 Aug 2015 Z-2478-2015 Class III Terminated The expiration date was incorrectly printed on the pouch/box labels of 19 products that were shipped to customer sites. The manufacturing date was accidentally used (copied) for the expiration date.
Frequently asked questions
How many devices does Abbott Electrophysiology have in the registry?
The registry currently lists 4 devices for Abbott Electrophysiology. Devices recorded under merged duplicate company entries are counted once.
Which registries list Abbott Electrophysiology's devices?
Among its 4 most recently registered devices, Abbott Electrophysiology has devices listed in FDA 510(k) (4 devices).
What risk classes do Abbott Electrophysiology's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Abbott Electrophysiology's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Abbott Electrophysiology?
FDA recall records list 1 recall initiated by Abbott Electrophysiology, the most recent initiated on 12 Aug 2015. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Abbott Electrophysiology in the registry?
The most recently registered devices listed for Abbott Electrophysiology include RhythmView Workstation, FIRMap Catheter and Rhythm View Workstation (non-streaming).