510(k) K110134 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
NC TREK RX CORONARY DILATATION CATHETER
| Applicant | Abbott Vascular-Cardiac Therapies, Temecula CA, US |
| Decision | Substantially Equivalent, Feb 11, 2011 |
| Received | Jan 18, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K110134
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 14, 2020 | Abbott Vascular NC TREK Coronary Dilatation Catheter, REF 1012453-08 Rx Only, NC TREK RX 4.00 X 8MM BDC
The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of Terminated |
LOX | None listed |
| Feb 14, 2020 | Abbott Vascular NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00 X 12MM BDC
The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion o Terminated |
LOX | None listed |
| Feb 14, 2020 | Abbott Vascular NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00 X 15MM BDC
The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion o Terminated |
LOX | None listed |
| Feb 14, 2020 | Abbott Vascular NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.00 X 20MM BDC
The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion o Terminated |
LOX | None listed |
| Feb 14, 2020 | Abbott Vascular NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC
The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of Terminated |
LOX | None listed |
| Feb 14, 2020 | Abbott Vascular NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC
The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of Terminated |
LOX | None listed |
| Feb 14, 2020 | Abbott Vascular NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50 X 15MM BDC
The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion o Terminated |
LOX | None listed |
| Feb 14, 2020 | Abbott Vascular NC TREK Coronary Dilatation Catheter, REF 1012454-20 Rx Only, NC TREK RX 4.50 X 20MM BDC
The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion o Terminated |
LOX | None listed |
| Feb 14, 2020 | Abbott Vascular NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00 X 8MM BDC
The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of Terminated |
LOX | None listed |
| Feb 14, 2020 | Abbott Vascular NC TREK Coronary Dilatation Catheter, REF 1012455-12 Rx Only, NC TREK RX 5.00 X 12MM BDC
The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion o Terminated |
LOX | None listed |
| Feb 14, 2020 | Abbott Vascular NC TREK Coronary Dilatation Catheter, REF 1012455-15 Rx Only,NC TREK RX 5.00 X 15MM BDC
The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of Terminated |
LOX | None listed |
| Feb 14, 2020 | Abbott Vascular NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00 X 20MM BDC
The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion o Terminated |
LOX | None listed |
| Feb 14, 2020 | Abbott Vascular NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC Traveler RX 4.0 X 8MM
The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United St Terminated |
LOX | None listed |
| Feb 14, 2020 | Abbott Vascular NC TRAVELER Coronary Dilatation Catheter, REF 1013157-12, Rx Only,NC Traveler RX 4.0 X 12MM
The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United S Terminated |
LOX | None listed |
| Feb 14, 2020 | Abbott Vascular NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC Traveler RX 4.0 X 15MM
The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United S Terminated |
LOX | None listed |
| Feb 14, 2020 | Abbott Vascular NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler RX 4.5 X 8MM
The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United St Terminated |
LOX | None listed |
| Feb 14, 2020 | Abbott Vascular NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC Traveler RX 4.5 X 12MM
The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United St Terminated |
LOX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.