510(k) K103153 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER
| Applicant | Abbott Vascular-Cardiac Therapies, Temecula CA, US |
| Decision | Substantially Equivalent, Dec 30, 2010 |
| Received | Oct 14, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103153
| 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 |
| May 12, 2017 | Abbott Vascular NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 1012448-12, 1012448-15, 1012448-20, 1012449-06, 1012449-08, 1012449-12, 1012449-15, 1012449-20, 1012449-25, 1012450-06, 101245 Terminated |
LOX | None listed |
| May 12, 2017 | Abbott Vascular NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15, 1013152-20, 1013153-08, 1013153-12, 1013153-15, 1013153-20, 1013154-08, 1013154-12, 1013154-15, 1013154-20, 1013155-08, 1 Terminated |
LOX | None listed |
| May 12, 2017 | Abbott Vascular NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T,
1012448-12T, 1012448-15T, 1012449-08T, 1012449-12T,
1012449-15T, 1012450-08T, 1012450-12T, 1012450-15T,
1012451-08T, 1012451-12T, 1012451-15T, Terminated |
LOX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.