Panels › Cardiovascular › Product code LOX · Class 2
Catheters, Transluminal Coronary Angioplasty, Percutaneous
Regulation 870.5100
6510(k)s in 12 months (88 all time)
0recalls in 12 months (121 all time)
29recalls that name a 510(k)
Top companies in LOX
| Company | 510(k)s | Recalls |
|---|---|---|
| Cordis Corporation | 0 | 83 |
| Abbott Vascular | 6 | 20 |
| Boston Scientific | 10 | 6 |
| Brosmed Medical | 5 | 0 |
| Ostial Corporation | 5 | 0 |
| Trireme Medical, Inc. | 5 | 0 |
| Medtronic, Inc. | 2 | 2 |
| Medtronic Ireland | 4 | 0 |
| Medtronic Vascular Galway DBA Medtronic Ireland | 0 | 4 |
| Orbusneich Medical, Inc. | 4 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 24, 2022 | Medtronic Inc Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a coaxial shaft with a balloon mounted on its distal tip. Open, Classified |
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 | K103153 K110134 |
| 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 | K103153 K110134 |
| 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 | K103153 K110134 |
| 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 | K103153 K110134 |
| 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 | K103153 K110134 |
| 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 | K103153 K110134 |
| 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 | K103153 K110134 |
| 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 | K103153 K110134 |
| 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 | K103153 K110134 |
| 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 | K103153 K110134 |
| 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 | K103153 K110134 |
| 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 | K103153 K110134 |
| 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 | K103153 K110134 |
| 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 | K103153 K110134 |
| 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 | K103153 K110134 |
| 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 | K103153 K110134 |
| 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 | K103153 K110134 |
| Oct 24, 2019 | Boston Scientific Corporation NC Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes:
1. REF/Catalog No. H7493926708350, NC EMERGE MR US 3.50MM X 8MM;
2. REF/Catalog No Terminated |
LOX | K141236 |
| Oct 24, 2019 | Boston Scientific Corporation Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493919308200 EMERGE MR, OUS 2.00mm X 8mm;
2. REF/Catalog No. H749 Terminated |
LOX | K113220 K121196 +2 |
| Sep 3, 2019 | Medtronic Vascular Galway DBA Medtronic Ireland Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC1506X, SLC1510X, SLC1512X, SLC1515X, SLC1520X, SLC2006X, SLC2010X, SLC2012X, SLC2015X, SLC2020X, SLC2025X, SLC2030X, SLC22510X Open, Classified |
LOX | None listed |
| Sep 3, 2019 | Medtronic Vascular Galway DBA Medtronic Ireland Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X, EUP2006X, EUP2010X, EUP2012X, EUP2015X, EUP2020X, EUP2025X, EUP2030X, EUP22506X Open, Classified |
LOX | K143480 |
| Sep 20, 2017 | Medtronic Vascular Galway DBA Medtronic Ireland Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. Terminated |
LOX | K143480 |
| Sep 20, 2017 | Medtronic Vascular Galway DBA Medtronic Ireland Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. Terminated |
LOX | K143480 |
| 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 | K103153 |
| 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 | K103153 |
| 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 | K103153 |
| Aug 28, 2014 | Cordis Corporation Cordis EMPIRA RX PTCA Dilatation Catheter Terminated |
LOX | K110133 |
| Aug 28, 2014 | Cordis Corporation Cordis EMPIRA NC RX PTCA Dilatation Catheter Terminated |
LOX | K110133 |
| Jun 11, 2014 | Cordis Corporation Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use. Terminated |
LOX | K110133 |
| Sep 30, 2013 | Medtronic Vascular, Inc. NC Sprinter; Rapid Exchange Balloon Dilatation Catheter;
Sterile; 2.25 mm; Model NCSP22512X.
Manufacturer: Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432
The NC Sprinter Rapid Exchange B Terminated |
LOX | None listed |
| Sep 21, 2012 | Cordis Corporation Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Balloon Length/mm 15 Usable Catheter Length/cm 150***Lot 50026688***2013-09***Cordis***PTA Dilatation Catheter***Cordis***Johnso Terminated |
LOX | None listed |
| Sep 21, 2012 | Cordis Corporation Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon Length/mm***15***Usable Catheter Length/cm***150*** Lot 50027149***2013-09***Cordis*** Sleek***OTW***REF Cat. No. 426-1201 Terminated |
LOX | None listed |
| Feb 3, 2009 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation VOYAGER NC Coronary Dilatation Catheter, 4.5 X 12.0 mm.
The device is used for in the following: (1) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the Terminated |
LOX | None listed |
| Dec 24, 2008 | Boston Scientific Corporation Flextome Cutting Balloon Device Over-the-Wire Delivery System, Coronary Atherotomy System, Over-the-Wire Delivery System, Catalog No. CB0340006, 4.00mm, Sterile. Made in Ireland: Interventional Tec Terminated |
LOX | None listed |
| Aug 26, 2008 | Boston Scientific Corporation Boston Scientific Scimed Maverick 2 Monorail 12mm Balloon Catheter, 2.5 mm x 12 mm
Made in Ireland Ballybrit Business Park, Galway, Ireland
REF 38928-1225
Use before 2007-01
UPN H7493892812250
Steril Terminated |
LOX | None listed |
| Aug 26, 2008 | Boston Scientific Corporation Boston Scientific Scimed Maverick 2 Monorail" PTCA Catheter, 3.0 mm 15 mm
REF 38928-1530
Lot 9565194
Use before 2010-04
Indicated for balloon dilation of the stenotic portion of a coronary artery Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 3.50 x 30 Dilatation Catheter, Catalog # 80130350, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 3.25 x 30 Dilatation Catheter, Catalog # 80130325, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 3.00 x 30 Dilatation Catheter, Catalog # 80130300, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 2.75 x 30 Dilatation Catheter, Catalog # 80130275, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 2.50 x 30 Dilatation Catheter, Catalog # 80130250, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 2.25 x 30 Dilatation Catheter, Catalog # 80130225, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 2.00 x 30, Single Marker Band, Dilatation Catheter, Catalog # 8013020S, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 2.00 x 30, Dual Marker Band, Dilatation Catheter, Catalog # 8013020D, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 3.50 x 20 Dilatation Catheter, Catalog # 80120350, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 3.25 x 20 Dilatation Catheter, Catalog # 80120325, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 3.00 x 20 Dilatation Catheter, Catalog # 80120300, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 2.75 x 20 Dilatation Catheter, Catalog # 80120275, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 2.50 x 20 Dilatation Catheter, Catalog # 80120250, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
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