Company ยท US
Abbott Electrophysiology
FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2017. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 1, 2017 | K171583 | RhythmView Workstation Abbott Electrophysiology | DQK |
| Feb 28, 2017 | K163709 | FIRMap Catheter Abbott Electrophysiology | MTD |
| Aug 10, 2016 | K161240 | Rhythm View Workstation (non-streaming) Abbott Electrophysiology | DQK |
| Apr 7, 2016 | K153093 | FIRMap Catheter Abbott Electrophysiology | MTD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 28, 2015 | Abbott Electrophysiology 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 t Terminated |
MTD | K130827 |