NC Trek NEO™
NC TREK NEO™ Coronary Dilatation Catheter 5.50 mm X 20 mm / Rapid-Exchange
12manufacturers in China registered for this device type
65catalogue numbers in this listing
6510(k) clearances naming this product code
21recalls on this code
Who Else Makes It
Concentrated in Jiangsu (4), Guangdong (3), Beijing (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| OrbusNeich Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Complaint-file establishment | 5 |
| Brosmed Medical Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Dongguan TT Medical, Inc. | Dongguan | Guangdong | Manufacturer | 4 |
| Kossel Medtech (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 4 |
| Shanghai Microport Medical (Group) Co., Ltd. | Shanghai | Shanghai | Specification developer | 1 |
| Sino Medical Sciences Technology Inc. | Tianjin | Tianjin | Manufacturer | 1 |
Record
| Listed by | Abbott Vascular, United States |
|---|---|
| FDA product code | LOX |
| Device type | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5100 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2022-08-15 |
| Record revised | 2024-03-25 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Although these devices have been tested for proper function after exposure to excursions of extreme temperatures (55 °C |
| Sizes | Balloon diameter 1.5 to 6 mm; balloon length 6 to 25 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1400550-20 | Balloon Diameter 5.5000 mm | In distribution |
| 1400275-20 | Balloon Length 20.0000 mm | In distribution |
| 1400325-20 | Balloon Diameter 3.2500 mm | In distribution |
| 1400375-12 | Balloon Diameter 3.7500 mm | In distribution |
| 1400600-20 | Balloon Diameter 6.0000 mm | In distribution |
| 1400325-15 | Balloon Diameter 3.2500 mm | In distribution |
| 1400400-15 | Balloon Length 15.0000 mm | In distribution |
| 1400325-08 | Balloon Diameter 3.2500 mm | In distribution |
| 1400250-08 | Balloon Length 8.0000 mm | In distribution |
| 1400350-20 | Balloon Diameter 3.5000 mm | In distribution |
| 1400225-08 | Balloon Diameter 2.2500 mm | In distribution |
| 1400225-20 | Balloon Diameter 2.2500 mm | In distribution |
| 1400375-15 | Balloon Diameter 3.7500 mm | In distribution |
| 1400325-06 | Balloon Length 6.0000 mm | In distribution |
| 1400500-12 | Balloon Length 12.0000 mm | In distribution |
| 1400200-15 | Balloon Length 15.0000 mm | In distribution |
| 1400550-15 | Balloon Length 15.0000 mm | In distribution |
| 1400200-08 | In distribution | |
| 1400200-06 | Balloon Diameter 2.0000 mm | In distribution |
| 1400225-12 | Balloon Length 12.0000 mm | In distribution |
| 1400250-15 | Balloon Diameter 2.5000 mm | In distribution |
| 1400250-25 | Balloon Length 25.0000 mm | In distribution |
| 1400275-06 | Balloon Length 6.0000 mm | In distribution |
| 1400250-12 | Balloon Diameter 2.5000 mm | In distribution |
| 1400450-08 | Balloon Length 8.0000 mm | In distribution |
| 1400200-12 | In distribution | |
| 1400600-12 | Balloon Length 12.0000 mm | In distribution |
| 1400225-15 | Balloon Length 15.0000 mm | In distribution |
| 1400250-20 | Balloon Length 20.0000 mm | In distribution |
| 1400375-08 | Balloon Length 8.0000 mm | In distribution |
| 1400350-08 | Balloon Diameter 3.5000 mm | In distribution |
| 1400275-15 | Balloon Length 15.0000 mm | In distribution |
| 1400300-15 | Balloon Diameter 3.0000 mm | In distribution |
| 1400300-12 | Balloon Length 12.0000 mm | In distribution |
| 1400500-08 | Balloon Diameter 5.0000 mm | In distribution |
| 1400450-12 | Balloon Diameter 4.5000 mm | In distribution |
| 1400400-20 | Balloon Diameter 4.0000 mm | In distribution |
| 1400400-08 | Balloon Diameter 4.0000 mm | In distribution |
| 1400150-06 | Balloon Length 6.0000 mm | In distribution |
| 1400150-12 | Balloon Diameter 1.5000 mm | In distribution |
| 1400300-25 | Balloon Length 25.0000 mm | In distribution |
| 1400150-08 | Balloon Diameter 1.5000 mm | In distribution |
| 1400250-06 | Balloon Diameter 2.5000 mm | In distribution |
| 1400450-15 | Balloon Length 15.0000 mm | In distribution |
| 1400300-06 | Balloon Diameter 3.0000 mm | In distribution |
| 1400225-06 | Balloon Length 6.0000 mm | In distribution |
| 1400400-12 | Balloon Diameter 4.0000 mm | In distribution |
| 1400350-12 | Balloon Diameter 3.5000 mm | In distribution |
| 1400275-12 | Balloon Diameter 2.7500 mm | In distribution |
| 1400150-20 | Balloon Diameter 1.5000 mm | In distribution |
| 1400500-15 | Balloon Diameter 5.0000 mm | In distribution |
| 1400275-08 | Balloon Diameter 2.7500 mm | In distribution |
| 1400450-20 | Balloon Diameter 4.5000 mm | In distribution |
| 1400350-15 | Balloon Diameter 3.5000 mm | In distribution |
| 1400200-20 | Balloon Length 20.0000 mm | In distribution |
| 1400375-20 | Balloon Length 20.0000 mm | In distribution |
| 1400350-25 | Balloon Diameter 3.5000 mm | In distribution |
| 1400550-12 | Balloon Diameter 5.5000 mm | In distribution |
| 1400500-20 | Balloon Length 20.0000 mm | In distribution |
| 1400300-08 | Balloon Length 8.0000 mm | In distribution |
| 1400325-12 | Balloon Diameter 3.2500 mm | In distribution |
| 1400300-20 | Balloon Length 20.0000 mm | In distribution |
| 1400350-06 | Balloon Length 6.0000 mm | In distribution |
| 1400600-15 | Balloon Diameter 6.0000 mm | In distribution |
| 1400150-15 | Balloon Length 15.0000 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| NC Emerge® | Boston Scientific Corporation | 144 |
| Sprinter® Legend | Medtronic, Inc. | 133 |
| NC Quantum Apex™ | Boston Scientific Corporation | 128 |
| Trek | Abbott Vascular | 120 |
| Emerge™ | Boston Scientific Corporation | 119 |
| NC Trek | Abbott Vascular | 118 |
| Apex™ | Boston Scientific Corporation | 116 |
| Maverick²™ | Boston Scientific Corporation | 113 |
| Apollo Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 110 |
| Sprinter® | Medtronic, Inc. | 108 |
| NC Stormer™ OTW | Medtronic, Inc. | 108 |
| Quantum™ Maverick™ | Boston Scientific Corporation | 106 |
Showing 12 of 67. All products under Catheters, Transluminal Coronary Angioplasty, Percutaneous
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220634 | 2022-06-30 |
| K180040 | 2018-08-24 |
| K123279 | 2013-01-30 |
| K121222 | 2012-06-22 |
| K113464 | 2012-03-06 |
| K110617 | 2011-06-02 |
Recalls
20 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-01-29 | Class I | Process change control | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Total 39687 NC TREK units (13891 US and 25796 OUS) | 2024-04-16 |
| 2020-01-29 | Class I | Process change control | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Total 791 Traveler (0 US and 791 OUS) | 2024-04-16 |
| 2020-01-29 | Class I | Process change control | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Total 791 Traveler (0 US and 791 OUS) | 2024-04-16 |
| 2020-01-29 | Class I | Process change control | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Total 39687 NC TREK units (13891 US and 25796 OUS) | 2024-04-16 |
| 2020-01-29 | Class I | Process change control | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Total 39687 NC TREK units (13891 US and 25796 OUS) | 2024-04-16 |
| 2020-01-29 | Class I | Process change control | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Total 791 Traveler (0 US and 791 OUS) | 2024-04-16 |
| 2020-01-29 | Class I | Process change control | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Total 39687 NC TREK units (13891 US and 25796 OUS) | 2024-04-16 |
| 2020-01-29 | Class I | Process change control | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Total 39687 NC TREK units (13891 US and 25796 OUS) | 2024-04-16 |
| 2020-01-29 | Class I | Process change control | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Total 39687 NC TREK units (13891 US and 25796 OUS) | 2024-04-16 |
| 2020-01-29 | Class I | Process change control | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Total 39687 NC TREK units (13891 US and 25796 OUS) | 2024-04-16 |
| 2020-01-29 | Class I | Process change control | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Total 39687 NC TREK (13891 US and 25796 OUS) | 2024-04-16 |
| 2020-01-29 | Class I | Process change control | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Total 39687 NC TREK units (13891 US and 25796 OUS) | 2024-04-16 |
| 2020-01-29 | Class I | Process change control | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Total 39687 NC TREK units (13891 US and 25796 OUS) | 2024-04-16 |
| 2020-01-29 | Class I | Process change control | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Total 791 Traveler (0 US and 791 OUS) | 2024-04-16 |
| 2020-01-29 | Class I | Process change control | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Total 39687 NC TREK units (13891 US and 25796 OUS) | 2024-04-16 |
| 2020-01-29 | Class I | Process change control | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Total 39687 NC TREK units (13891 US and 25796 OUS) | 2024-04-16 |
| 2020-01-29 | Class I | Process change control | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Total 791 Traveler (0 US and 791 OUS) | 2024-04-16 |
| 2017-03-22 | Class I | Device Design | Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon. | 449,661 units total (132,040 units in US) | 2018-02-07 |
| 2017-03-22 | Class I | Device Design | Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon. | 449,661 units total (132,040 units in US) | 2018-02-07 |
| 2017-03-22 | Class I | Device Design | Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon. | 449,661 units total (132,040 units in US) | 2018-02-07 |
| 2008-11-05 | Not classified | Package design/selection | The recall was initiated after Abbott Vascular received reports that, in a small percentage of cases, the protective, yellow balloon sheath of the 4.5mm diameter VOYAGER NC Coronary Dilatation Catheter has been tight. If unnoticed by the u | 126 units | 2012-08-13 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P020037 | 2003-06-11 | FX MINIRAIL RX PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER | Abbott Vascular |
| P790017 | 2003-03-04 | NC STORMER OVER-THE-WIRE BALLOON DILATATION CATHETER AND NC STORMER ZIPPER MX BALLOON DILATATION CATHETER | Medtronic Ireland |
| P880027 | 2002-06-25 | PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) | Boston Scientific Corporation |
| P860019 | 2000-12-08 | MAXXUM AND NC MAXXUM PTCA CATHETER | Scimed Life Systems, Inc. |
| P880003 | 2000-07-07 | NINJA FX PTCA DILATATION CATHETER | Cordis Corp. |
| P990008 | 1999-09-27 | COOK MBC PTCA BALLOON DILATATION CATHETER | Cook Incorporated |
| P960014 | 1998-10-05 | MAGELLAN-C PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY(PTCA) CATHETERS MODEL C22020,C22520,C23020,& C23520 | Global Therapeutics, Inc. |
| P970052 | 1998-04-08 | LYNX CONTOUR CORONARY BALLOON DILATATION CATHETER(A NEW MODEL OF THE FACT CATHETER). | Endologix LLC |
| P930012 | 1997-05-29 | THE WRAP(PTCA) CATHETER | Progressive Angioplasty Systems, Inc. |
| P910031 | 1996-12-02 | FACT(TM)AND ARC BALLOON CORNARY DILATATION CATHETERS | Abbott Vascular Devices |
| P890048 | 1996-11-26 | USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS | Usci, Div. C.R. Bard, Inc. |
| P890001 | 1996-06-07 | LEOCOR PICO RUNNER(TM) PTCA CATHETER | Leocor, Inc. |
| P850021 | 1995-07-12 | HYBRID (PTCA) CATHETER | Abbott Vascular |
| P940009 | 1994-09-29 | PERCUTANEUS TRANSLUMINAL CORONARY ANGIOPLASTY CATH | Scimed Life Systems, Inc. |
| P890032 | 1992-07-23 | CORDIS ORION STEERABLE PTCA BALLOON CATHETER | Cordis Corp. |
| P880055 | 1991-07-19 | MICROSS-SL(TM) PTCA DILATATION CATHETER | Boston Scientific Corporation |
| P840040 | 1991-01-30 | HEART TRAK PTCA CATHETER | Boston Scientific Corporation |
| P810046 | 1990-10-05 | ACS RX(R) –.014 CORONARY DILATATION CATHETER | Advanced Cardiovascular Systems, Inc. |
| P870021 | 1990-10-04 | PRIME{TM} MODEL 6520, 6525, 6530 AND 6535 | Medtronic, Inc. |
| P880065 | 1990-09-19 | MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER | Boston Scientific Corporation |
| P870036 | 1989-06-23 | VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM | Medtronics Interventional Vascular |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.