Abbott Electrophysiology
Menlo Park, CA, US
Abbott Electrophysiology appears in FDA device records in Menlo Park, CA. FDA records list 4 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Abbott Electrophysiology between 2016 and 2017. The busiest year on record is 2016, with 2. The most recent is 2017, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 2 |
| 2017 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K171583 | RhythmView Workstation | DQK | Substantially Equivalent | |
| K163709 | FIRMap Catheter | MTD | Substantially Equivalent | |
| K161240 | Rhythm View Workstation (non-streaming) | DQK | Substantially Equivalent | |
| K153093 | FIRMap Catheter | MTD | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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. | 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. | Class III | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain