NC Rockstar
NC Rockstar is a rapid-exchange balloon catheter used to dilate narrowed coronary arteries or bypass grafts and to expand balloon-expandable coronary stents after placement. A…
NC Rockstar is a rapid-exchange balloon catheter used to dilate narrowed coronary arteries or bypass grafts and to expand balloon-expandable coronary stents after placement. A low-compliance balloon near the tip is inflated and deflated through a luer connection at the proximal end.
The distal shaft has separate paths for balloon inflation and a guidewire up to 0.014 inches in diameter. A stainless steel hypotube forms the proximal shaft, while a tapered tip and radiopaque marker bands support advancement and positioning under fluoroscopy.
Listed Item
The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion in patients with atherosclerosis. The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting).
Balloon and Shaft
The catheter has a usable length of 145 cm. Balloon options span 2.00 to 5.00 mm in diameter and 8 to 20 mm in length. The balloon has a hydrophobic coating; the shaft segment from the guidewire port to just before the balloon has a hydrophilic coating.
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 | Sino Medical Sciences Technology Inc., China |
|---|---|
| FDA product code | LOX |
| Device type | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5100 |
| Establishment | Manufacturer |
| 510(k) | K222538 |
| Record published | 2023-07-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | expiry date, serial number |
| Storage | Special storage condition: Store in a cool, dry, dark place. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NCP-5.00-12-RX | In distribution | |
| NCP-5.00-08-RX | In distribution | |
| NCP-4.50-20-RX | In distribution | |
| NCP-3.75-20-RX | In distribution | |
| NCP-3.00-12-RX | In distribution | |
| NCP-3.00-08-RX | In distribution | |
| NCP-2.75-20-RX | In distribution | |
| NCP-5.00-20-RX | In distribution | |
| NCP-3.50-12-RX | In distribution | |
| NCP-3.50-08-RX | In distribution | |
| NCP-2.25-12-RX | In distribution | |
| NCP-4.00-08-RX | In distribution | |
| NCP-3.75-08-RX | In distribution | |
| NCP-3.25-12-RX | In distribution | |
| NCP-4.50-08-RX | In distribution | |
| NCP-4.50-12-RX | In distribution | |
| NCP-2.50-20-RX | In distribution | |
| NCP-3.00-20-RX | In distribution | |
| NCP-3.50-20-RX | In distribution | |
| NCP-2.25-08-RX | In distribution | |
| NCP-2.50-15-RX | In distribution | |
| NCP-3.25-08-RX | In distribution | |
| NCP-4.00-12-RX | In distribution | |
| NCP-3.00-15-RX | In distribution | |
| NCP-4.00-15-RX | In distribution | |
| NCP-2.00-12-RX | In distribution | |
| NCP-3.75-12-RX | In distribution | |
| NCP-2.50-12-RX | In distribution | |
| NCP-5.00-15-RX | In distribution | |
| NCP-2.50-08-RX | In distribution | |
| NCP-2.00-20-RX | In distribution | |
| NCP-4.00-20-RX | In distribution | |
| NCP-2.75-15-RX | In distribution | |
| NCP-2.75-12-RX | In distribution | |
| NCP-3.50-15-RX | In distribution | |
| NCP-2.25-20-RX | In distribution | |
| NCP-2.25-15-RX | In distribution | |
| NCP-3.75-15-RX | In distribution | |
| NCP-3.25-20-RX | In distribution | |
| NCP-3.25-15-RX | In distribution | |
| NCP-2.00-15-RX | In distribution | |
| NCP-2.00-08-RX | In distribution | |
| NCP-4.50-15-RX | In distribution | |
| NCP-2.75-08-RX | 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 |
|---|---|
| K223022 | 2023-02-15 |
| K222538 | 2022-12-21 |
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.