Emerge™
119 catalogue numbers from H7493919120400, listed by Boston Scientific Corporation, United States, under Catheters, Transluminal Coronary Angioplasty, Percutaneous. 12 manufacturers in China are registered for this product code.
12manufacturers in China registered for this device type
119catalogue numbers in this listing
10510(k) clearances naming this product code
7recalls 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 | Boston Scientific Corporation, 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, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2019-10-07 (version 3) |
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 |
| Sizes | Balloon length 8 to 40 mm; balloon diameter 2 to 5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| H7493919120400 | 20 mm Length | In distribution |
| H7493918908270 | 8 mm Length | In distribution |
| H7493919115270 | 2.75 mm Diameter | In distribution |
| H7493918912400 | 12 mm Length | In distribution |
| H7493918908120 | 8 mm Length | In distribution |
| H7493919112300 | 3.00 mm Diameter | In distribution |
| H7493919115320 | 3.25 mm Diameter | In distribution |
| H7493918920450 | Balloon Length 20 mm | In distribution |
| H7493918920500 | Balloon Length 20 mm | In distribution |
| H7493919120350 | 20 mm Length | In distribution |
| H7493919108250 | 8 mm Length | In distribution |
| H7493918920370 | 20 mm Length | In distribution |
| H7493919112220 | 12 mm Length | In distribution |
| H7493918930200 | 30 mm Length | In distribution |
| H7493919115350 | 15 mm Length | In distribution |
| H7493919130320 | 30 mm Length | In distribution |
| H7493918915150 | 15 mm Length | In distribution |
| H7493918912300 | 3.00 mm Diameter | In distribution |
| H7493918908350 | 8 mm Length | In distribution |
| H7493919112350 | 3.50 mm Diameter | In distribution |
| H7493918908250 | 8 mm Length | In distribution |
| H7493918940400 | Balloon Length 40 mm | In distribution |
| H7493918915300 | 3.00 mm Diameter | In distribution |
| H7493918915120 | 1.20 mm Diameter | In distribution |
| H7493919108320 | 8 mm Length | In distribution |
| H7493918908150 | 1.50 mm Diameter | In distribution |
| H7493919112400 | 12 mm Length | In distribution |
| H7493918912320 | 12 mm Length | In distribution |
| H7493918920120 | 20 mm Length | In distribution |
| H7493919115400 | 4.00 mm Diameter | In distribution |
| H7493919120370 | 20 mm Length | In distribution |
| H7493919112120 | 12 mm Length | In distribution |
| H7493919115250 | 15 mm Length | In distribution |
| H7493918930300 | 3.00 mm Diameter | In distribution |
| H7493919115120 | 15 mm Length | In distribution |
| H7493919130270 | 2.75 mm Diameter | In distribution |
| H7493919108150 | 8 mm Length | In distribution |
| H7493919112150 | 12 mm Length | In distribution |
| H7493918915450 | Balloon Length 15 mm | In distribution |
| H7493919108370 | 3.75 mm Diameter | In distribution |
| H7493919108270 | 2.75 mm Diameter | In distribution |
| H7493918908220 | 8 mm Length | In distribution |
| H7493919130350 | 30 mm Length | In distribution |
| H7493919108200 | 2.00 mm Diameter | In distribution |
| H7493919108120 | 1.20 mm Diameter | In distribution |
| H7493918908300 | 8 mm Length | In distribution |
| H7493919108350 | 3.50 mm Diameter | In distribution |
| H7493918912150 | 1.50 mm Diameter | In distribution |
| H7493918920200 | 2.00 mm Diameter | In distribution |
| H7493918920350 | 20 mm Length | In distribution |
| H7493918912250 | 12 mm Length | In distribution |
| H7493918908450 | Balloon Diameter 4.5 mm | In distribution |
| H7493918915270 | 15 mm Length | In distribution |
| H7493919115150 | 15 mm Length | In distribution |
| H7493918930250 | 2.50 mm Diameter | In distribution |
| H7493918912450 | Balloon Diameter 4.5 mm | In distribution |
| H7493918920150 | 20 mm Length | In distribution |
| H7493919112270 | 12 mm Length | In distribution |
| H7493918912270 | 2.75 mm Diameter | In distribution |
| H7493918930370 | 3.75 mm Diameter | In distribution |
| H7493918940250 | Balloon Diameter 2.5 mm | In distribution |
| H7493918915250 | 2.50 mm Diameter | In distribution |
| H7493918908400 | 8 mm Length | In distribution |
| H7493918930220 | 2.25 mm Diameter | In distribution |
| H7493918912200 | 12 mm Length | In distribution |
| H7493918920320 | 20 mm Length | In distribution |
| H7493918940350 | Balloon Diameter 3.5 mm | In distribution |
| H7493918930350 | 3.50 mm Diameter | In distribution |
| H7493919120150 | 20 mm Length | In distribution |
| H7493918920300 | 3.00 mm Diameter | In distribution |
| H7493919108400 | 4.00 mm Diameter | In distribution |
| H7493919108220 | 2.25 mm Diameter | In distribution |
| H7493919112250 | 12 mm Length | In distribution |
| H7493919120270 | 2.75 mm Diameter | In distribution |
| H7493919120250 | 20 mm Length | In distribution |
| H7493919120320 | 3.25 mm Diameter | In distribution |
| H7493918920220 | 2.25 mm Diameter | In distribution |
| H7493918908370 | 8 mm Length | In distribution |
| H7493918912350 | 3.50 mm Diameter | In distribution |
| H7493919115200 | 15 mm Length | In distribution |
| H7493919115220 | 2.25 mm Diameter | In distribution |
| H7493919112370 | 3.75 mm Diameter | In distribution |
| H7493918930320 | 3.25 mm Diameter | In distribution |
| H7493918915200 | 15 mm Length | In distribution |
| H7493918908200 | 8 mm Length | In distribution |
| H7493918920400 | 4.00 mm Diameter | In distribution |
| H7493919130200 | 2.00 mm Diameter | In distribution |
| H7493918940300 | Balloon Length 40 mm | In distribution |
| H7493918915400 | 4.00 mm Diameter | In distribution |
| H7493919120220 | 2.25 mm Diameter | In distribution |
| H7493918915350 | 3.50 mm Diameter | In distribution |
| H7493919112200 | 12 mm Length | In distribution |
| H7493918920250 | 2.50 mm Diameter | In distribution |
| H7493918912370 | 12 mm Length | In distribution |
| H7493919130300 | 3.00 mm Diameter | In distribution |
| H7493919130250 | 30 mm Length | In distribution |
| H7493918912500 | Balloon Diameter 5 mm | In distribution |
| H7493919120300 | 3.00 mm Diameter | In distribution |
| H7493918908500 | Balloon Length 8 mm | In distribution |
| H7493919130370 | 30 mm Length | In distribution |
| H7493919115370 | 15 mm Length | In distribution |
| H7493919120120 | 1.20 mm Diameter | In distribution |
| H7493918915320 | 3.25 mm Diameter | In distribution |
| H7493918915500 | Balloon Diameter 5 mm | In distribution |
| H7493918920270 | 2.75 mm Diameter | In distribution |
| H7493918912220 | 2.25 mm Diameter | In distribution |
| H7493919130400 | 4.00 mm Diameter | In distribution |
| H7493919120200 | 2.00 mm Diameter | In distribution |
| H7493918930270 | 2.75 mm Diameter | In distribution |
| H7493919112320 | 12 mm Length | In distribution |
| H7493918915220 | 15 mm Length | In distribution |
| H7493919115300 | 15 mm Length | In distribution |
| H7493918908320 | 3.25 mm Diameter | In distribution |
| H7493918912120 | 12 mm Length | In distribution |
| H7493918915370 | 3.75 mm Diameter | In distribution |
| H7493919108300 | 8 mm Length | In distribution |
| H7493919130220 | 30 mm Length | In distribution |
| H7493918940200 | Balloon Diameter 2 mm | In distribution |
| H7493918930400 | 30 mm Length | 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 |
| 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 |
| Sapphire NC 24 Coronary Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 98 |
Showing 12 of 67. All products under Catheters, Transluminal Coronary Angioplasty, Percutaneous
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220629 | 2022-03-24 |
| K163174 | 2016-12-14 |
| K163200 | 2016-12-14 |
| K160823 | 2016-06-23 |
| K141236 | 2014-08-07 |
| K134031 | 2014-07-21 |
| K130391 | 2013-07-10 |
| K121196 | 2012-08-31 |
| K121667 | 2012-08-13 |
| K113220 | 2012-03-22 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-10-24 | Class II | Process control | Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process. | 14,145 devices total | 2023-03-20 |
| 2019-10-24 | Class II | Process control | Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process. | 14,145 devices total | 2023-03-20 |
| 2008-11-21 | Not classified | Mixed-up of materials/components | For one batch/lot of flextome Cutting Balloon (OTW), an incorrect compliance chart was packaged inside the sterile pouch. For the affected batch/lot, the compliance chart packed inside the pouch of the 4.0mm diameter Flextome Cutting Ballo | 75 | 2011-12-10 |
| 2006-07-21 | Not classified | Other | Lack of assurance of sterility (pre-sterilization bioburden limits exceeded) | 1,000 | 2007-02-03 |
| 2003-08-20 | Not classified | Other | Some of the recalled catheters have a component that has levels of pyrogens above specification. | 2 catheters | 2005-10-24 |
| 2003-08-20 | Not classified | Other | Some of the recalled catheters have a component that has levels of pyrogens above specification. | 9 catheters | 2005-10-24 |
| 2003-08-20 | Not classified | Other | Some of the recalled catheters have a component that has levels of pyrogens above specification. | 6 catheters | 2005-10-24 |
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.