Sapphire Ultra Coronary Dilatation Catheter
Sapphire Ultra is a rapid-exchange coronary balloon catheter for dilating narrowed coronary arteries or bypass grafts. A semicompliant balloon is inflated through the catheter's proximal…
Sapphire Ultra is a rapid-exchange coronary balloon catheter for dilating narrowed coronary arteries or bypass grafts. A semicompliant balloon is inflated through the catheter’s proximal luer connection.
The proximal shaft is PTFE-coated stainless steel, transitioning to a distal inner and outer tube assembly. The catheter tracks over a standard 0.014-inch guidewire through its rapid-exchange lumen.
Balloon and Marker Options
Balloon diameters range from 1.0 to 4.0 mm. The 1.0 to 1.5 mm configurations have one central platinum marker, while larger versions use two markers. The 1.0 and 1.25 mm models are intended for predilatation; the larger specified models have broader coronary dilatation applications. The rated balloon burst pressure is 14 atmospheres.
12manufacturers in China registered for this device type
45catalogue numbers in this listing
3510(k) clearances naming this product 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 | OrbusNeich Medical (Shenzhen) Co., Ltd., China |
|---|---|
| FDA product code | LOX |
| Device type | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5100 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K233505 |
| Record published | 2025-02-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7917-020-11 | In distribution | |
| 7910-010-11 | In distribution | |
| 7922-010-11 | In distribution | |
| 7930-010-11 | In distribution | |
| 7925-020-11 | In distribution | |
| 7930-015-11 | In distribution | |
| 7935-030-11 | In distribution | |
| 7917-015-11 | In distribution | |
| 7917-010-11 | In distribution | |
| 7927-020-11 | In distribution | |
| 7925-030-11 | In distribution | |
| 7930-012-11 | In distribution | |
| 7932-015-11 | In distribution | |
| 7912-015-11 | In distribution | |
| 7915-015-11 | In distribution | |
| 7910-008-11 | In distribution | |
| 7910-005-11 | In distribution | |
| 7910-015-11 | In distribution | |
| 7915-020-11 | In distribution | |
| 7930-030-11 | In distribution | |
| 7920-012-11 | In distribution | |
| 7922-015-11 | In distribution | |
| 7930-020-11 | In distribution | |
| 7915-012-11 | In distribution | |
| 7935-010-11 | In distribution | |
| 7935-015-11 | In distribution | |
| 7925-012-11 | In distribution | |
| 7935-020-11 | In distribution | |
| 7925-010-11 | In distribution | |
| 7927-010-11 | In distribution | |
| 7922-020-11 | In distribution | |
| 7915-010-11 | In distribution | |
| 7940-015-11 | In distribution | |
| 7920-020-11 | In distribution | |
| 7932-020-11 | In distribution | |
| 7920-015-11 | In distribution | |
| 7927-015-11 | In distribution | |
| 7920-010-11 | In distribution | |
| 7925-015-11 | In distribution | |
| 7912-010-11 | In distribution | |
| 7912-008-11 | In distribution | |
| 7940-020-11 | In distribution | |
| 7912-005-11 | In distribution | |
| 7940-010-11 | In distribution | |
| 7932-010-11 | 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 |
|---|---|
| K233499 | 2024-08-16 |
| K233505 | 2024-08-15 |
| K211807 | 2021-10-14 |
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.