ConcierGE Guiding Excellence™
295 catalogue numbers from 00884450036181, listed by Merit Medical Systems, Inc., United States, under Catheter, Percutaneous. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
295catalogue numbers in this listing
6510(k) clearances naming this product code
3recalls on this code
Who Else Makes It
Concentrated in Shanghai (5), Jiangsu (5), Guangdong (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Covidien Medical Products (Shanghai) Manufacturing LLC | Shanghai | Shanghai | Contract manufacturer | 8 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| 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 Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
| OrbusNeich Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Complaint-file establishment | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Shanghai Wallaby Medical Technologies Co., Inc. | Shanghai | Shanghai | Contract manufacturer | 5 |
| DK Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Showing 12 of 14. All 14 manufacturers in China registered for Catheter, Percutaneous
Record
| Listed by | Merit Medical Systems, Inc., United States |
|---|---|
| FDA product code | DQY |
| Device type | Catheter, Percutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2023-09-28 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00884450036181 | French Size (F)-5F | In distribution |
| 00884450037478 | Catheter Shape-Judkins Right 3.5 | In distribution |
| 00884450036259 | French Size (F)-5F | In distribution |
| 00884450106488 | Length-100 cm | In distribution |
| 00884450241936 | Catheter Shape-SBSLAD 4.5 | In distribution |
| 00884450036426 | Catheter Shape-Judkins Right 3.5 | In distribution |
| 00884450037232 | Internal Diameter-0.078″ (1.98 mm) | In distribution |
| 00884450036877 | Internal Diameter-0.070″ (1.78 mm) | In distribution |
| 00884450037065 | Catheter Shape-Judkins Right 3.5 | In distribution |
| 00884450036679 | French Size (F)-6F | In distribution |
| 00884450241769 | French Size (F)-6F | In distribution |
| 00884450242803 | Length-100 cm | In distribution |
| 00884450037256 | French Size (F)-8F | In distribution |
| 00884450036563 | French Size (F)-5F | In distribution |
| 00884450326138 | Catheter Shape-Judkins Left 4.0 | In distribution |
| 00884450241752 | Internal Diameter-0.070″ (1.78 mm) | In distribution |
| 00884450037003 | Internal Diameter-0.078″ (1.98 mm) | In distribution |
| 00884450036419 | Catheter Shape-Judkins Right 3.5 | In distribution |
| 00884450036266 | Catheter Shape-Hockey Stick | In distribution |
| 00884450037591 | Internal Diameter-0.088″ (2.24 mm) | In distribution |
| 00884450241929 | Internal Diameter-0.078″ (1.98 mm) | In distribution |
| 00884450037089 | French Size (F)-7F | In distribution |
| 00884450108598 | Internal Diameter-0.078″ (1.98 mm) | In distribution |
| 00884450036280 | Internal Diameter-0.057″ (1.45 mm) | In distribution |
| 00884450242537 | Internal Diameter-0.070″ (1.78 mm) | In distribution |
| 00884450119907 | Length-100 cm | In distribution |
| 00884450037690 | Catheter Shape-Judkins Right 6.0 | In distribution |
| 00884450037850 | Internal Diameter-0.078″ (1.98 mm) | In distribution |
| 00884450037560 | Catheter Shape-Right Coronary Bypass | In distribution |
| 00884450242551 | Internal Diameter-0.078″ (1.98 mm) | In distribution |
| 00884450086759 | Length-100 cm | In distribution |
| 00884450037355 | French Size (F)-8F | In distribution |
| 00884450036525 | Internal Diameter-0.057″ (1.45 mm) | In distribution |
| 00884450248454 | French Size (F)-5F | In distribution |
| 00884450036952 | Catheter Shape-Judkins Left 3.5 | In distribution |
| 00884450242605 | Catheter Shape-SBSLAD 3.5 | In distribution |
| 00884450242476 | Catheter Shape-SBSRCA | In distribution |
| 00884450242643 | French Size (F)-8F | In distribution |
| 00884450036372 | Internal Diameter-0.057″ (1.45 mm) | In distribution |
| 00884450123461 | French Size (F)-8F | In distribution |
| 00884450037881 | Length-100 cm | In distribution |
| 00884450123386 | Catheter Shape-Ultimate 1 | In distribution |
| 00884450037898 | Length-100 cm | In distribution |
| 00884450123485 | French Size (F)-8F | In distribution |
| 00884450036983 | Length-100 cm | In distribution |
| 00884450036242 | French Size (F)-5F | In distribution |
| 00884450036822 | French Size (F)-6F | In distribution |
| 00884450038628 | Internal Diameter-0.070″ (1.78 mm) | In distribution |
| 00884450241905 | Length-100 cm | In distribution |
| 00884450036204 | French Size (F)-5F | In distribution |
| 00884450037805 | Internal Diameter-0.070″ (1.78 mm) | In distribution |
| 00884450036327 | Catheter Shape-Judkins Left 3.5 (Short Tip) | In distribution |
| 00884450037393 | Internal Diameter-0.088″ (2.24 mm) | In distribution |
| 00884450057582 | Catheter Shape-Internal Mammary | In distribution |
| 00884450037409 | Length-100 cm | In distribution |
| 00884450036389 | Length-100 cm | In distribution |
| 00884450037263 | Length-100 cm | In distribution |
| 00884450242698 | Internal Diameter-0.088″ (2.24 mm) | In distribution |
| 00884450037638 | Length-100 cm | In distribution |
| 00884450118245 | French Size (F)-6F | In distribution |
| 00884450037041 | Length-100 cm | In distribution |
| 00884450123478 | Length-100 cm | In distribution |
| 00884450037485 | Catheter Shape-Judkins Right 4.0 | In distribution |
| 00884450037201 | French Size (F)-7F | In distribution |
| 00884450099476 | Catheter Shape-Renal Double Curve | In distribution |
| 00884450036792 | French Size (F)-6F | In distribution |
| 00884450037720 | Length-100 cm | In distribution |
| 00884450037744 | Internal Diameter-0.070″ (1.78 mm) | In distribution |
| 00884450242674 | Internal Diameter-0.088″ (2.24 mm) | In distribution |
| 00884450037133 | French Size (F)-7F | In distribution |
| 00884450037249 | French Size (F)-8F | In distribution |
| 00884450057759 | Length-100 cm | In distribution |
| 00884450242636 | Catheter Shape-SBSLAD 3.5 | In distribution |
| 00884450242544 | Internal Diameter-0.078″ (1.98 mm) | In distribution |
| 00884450036365 | Catheter Shape-Judkins Left 4.5 | In distribution |
| 00884450242469 | Length-100 cm | In distribution |
| 00884450326121 | Internal Diameter-0.078″ (1.98 mm) | In distribution |
| 00884450114957 | French Size (F)-6F | In distribution |
| 00884450101629 | Length-100 cm | In distribution |
| 00884450036686 | Catheter Shape-Amplatz Right 1 | In distribution |
| 00884450037584 | Internal Diameter-0.088″ (2.24 mm) | In distribution |
| 00884450037287 | Internal Diameter-0.088″ (2.24 mm) | In distribution |
| 00884450036532 | Length-100 cm | In distribution |
| 00884450037423 | Internal Diameter-0.088″ (2.24 mm) | In distribution |
| 00884450326107 | Internal Diameter-0.070″ (1.78 mm) | In distribution |
| 00884450241912 | French Size (F)-7F | In distribution |
| 00884450245996 | Length-100 cm | In distribution |
| 00884450241530 | French Size (F)-5F | In distribution |
| 00884450242568 | Length-100 cm | In distribution |
| 00884450123287 | Internal Diameter-0.057″ (1.45 mm) | In distribution |
| 00884450123492 | Internal Diameter-0.088″ (2.24 mm) | In distribution |
| 00884450037812 | French Size (F)-6F | In distribution |
| 00884450036860 | Length-100 cm | In distribution |
| 00884450037751 | Length-100 cm | In distribution |
| 00884450241790 | Internal Diameter-0.070″ (1.78 mm) | In distribution |
| 00884450241783 | Catheter Shape-SBSLAD 3.5 | In distribution |
| 00884450037904 | Length-100 cm | In distribution |
| 00884450241691 | Length-100 cm | In distribution |
| 00884450057865 | Internal Diameter-0.088″ (2.24 mm) | In distribution |
| 00884450036228 | Length-100 cm | In distribution |
| 00884450241738 | French Size (F)-6F | In distribution |
| 00884450036815 | Length-100 cm | In distribution |
| 00884450036846 | French Size (F)-6F | In distribution |
| 00884450241776 | Catheter Shape-SBSLAD 4.5 | In distribution |
| 00884450036150 | Internal Diameter-0.057″ (1.45 mm) | In distribution |
| 00884450037867 | Internal Diameter-0.078″ (1.98 mm) | In distribution |
| 00884450036167 | Length-100 cm | In distribution |
| 00884450123393 | French Size (F)-6F | In distribution |
| 00884450037829 | French Size (F)-7F | In distribution |
| 00884450036495 | Catheter Shape-Left Coronary Bypass | In distribution |
| 00884450037430 | Catheter Shape-Judkins Left 5.0 | In distribution |
| 00884450037379 | French Size (F)-8F | In distribution |
| 00884450036778 | Catheter Shape-Judkins Left 3.5 | In distribution |
| 00884450037669 | Length-100 cm | In distribution |
| 00884450241721 | Internal Diameter-0.057″ (1.45 mm) | In distribution |
| 00884450037171 | Internal Diameter-0.078″ (1.98 mm) | In distribution |
| 00884450037416 | French Size (F)-8F | In distribution |
| 00884450036341 | French Size (F)-5F | In distribution |
| 00884450070604 | French Size (F)-8F | In distribution |
| 00884450246054 | Internal Diameter-0.070″ (1.78 mm) | In distribution |
| 00884450045503 | Catheter Shape-SBS 3.5 (Mod) | In distribution |
| 00884450036631 | Internal Diameter-0.070″ (1.78 mm) | In distribution |
| 00884450036907 | French Size (F)-7F | In distribution |
| 00884450037157 | French Size (F)-7F | In distribution |
| 00884450037706 | Catheter Shape-Left Coronary Bypass | In distribution |
| 00884450241813 | French Size (F)-6F | In distribution |
| 00884450037027 | Length-100 cm | In distribution |
| 00884450248430 | French Size (F)-7F | In distribution |
| 00884450077146 | Internal Diameter-0.088″ (2.24 mm) | In distribution |
| 00884450241974 | Length-100 cm | In distribution |
| 00884450036761 | Internal Diameter-0.070″ (1.78 mm) | In distribution |
| 00884450036938 | Internal Diameter-0.078″ (1.98 mm) | In distribution |
| 00884450037454 | Length-100 cm | In distribution |
| 00884450037331 | Internal Diameter-0.088″ (2.24 mm) | In distribution |
| 00884450037188 | Internal Diameter-0.078″ (1.98 mm) | In distribution |
| 00884450246160 | Internal Diameter-0.088″ (2.24 mm) | In distribution |
| 00884450037034 | French Size (F)-7F | In distribution |
| 00884450036723 | Catheter Shape-El Gamal | In distribution |
| 00884450036471 | Length-100 cm | In distribution |
| 00884450241806 | Length-100 cm | In distribution |
| 00884450037546 | Catheter Shape-Multipurpose 1 | In distribution |
| 00884450110683 | Length-100 cm | In distribution |
| 00884450036808 | French Size (F)-6F | In distribution |
| 00884450037096 | Length-100 cm | In distribution |
| 00884450038635 | Internal Diameter-0.070″ (1.78 mm) | In distribution |
| 00884450246122 | Internal Diameter-0.078″ (1.98 mm) | In distribution |
| 00884450036211 | Length-100 cm | In distribution |
| 00884450242667 | French Size (F)-8F | In distribution |
| 00884450070598 | French Size (F)-7F | In distribution |
| 00884450232163 | Catheter Shape-Ultimate 4-T45 | In distribution |
| 00884450242995 | Catheter Shape-SBSLAD 4.5 | In distribution |
| 00884450241745 | Catheter Shape-SBSLAD 3.0 | In distribution |
| 00884450036556 | Internal Diameter-0.057″ (1.45 mm) | In distribution |
| 00884450037294 | Internal Diameter-0.078″ (1.98 mm) | In distribution |
| 00884450123676 | Internal Diameter-0.070″ (1.78 mm) | In distribution |
| 00884450241707 | French Size (F)-5F | In distribution |
| 00884450232101 | Catheter Shape-Ultimate 4-T40 | In distribution |
| 00884450123683 | Internal Diameter-0.078″ (1.98 mm) | In distribution |
| 00884450123669 | Internal Diameter-0.057″ (1.45 mm) | In distribution |
| 00884450057766 | Catheter Shape-Judkins Right 6.0 | In distribution |
| 00884450036884 | French Size (F)-6F | In distribution |
| 00884450326152 | French Size (F)-7F | In distribution |
| 00884450037140 | Length-100 cm | In distribution |
| 00884450037317 | French Size (F)-8F | In distribution |
| 00884450036273 | Internal Diameter-0.057″ (1.45 mm) | In distribution |
| 00884450326114 | Internal Diameter-0.070″ (1.78 mm) | In distribution |
| 00884450057858 | French Size (F)-8F | In distribution |
| 00884450054253 | Catheter Shape-SBS 4.0 (Mod) | In distribution |
| 00884450036655 | Length-100 cm | In distribution |
| 00884450037843 | French Size (F)-7F | In distribution |
| 00884450036624 | French Size (F)-6F | In distribution |
| 00884450037515 | Internal Diameter-0.088″ (2.24 mm) | In distribution |
| 00884450241554 | Internal Diameter-0.057″ (1.45 mm) | In distribution |
| 00884450036891 | Internal Diameter-0.078″ (1.98 mm) | In distribution |
| 00884450242827 | French Size (F)-6F | In distribution |
| 00884450037607 | French Size (F)-8F | In distribution |
| 00884450106327 | Internal Diameter-0.078″ (1.98 mm) | In distribution |
| 00884450036662 | French Size (F)-6F | In distribution |
| 00884450242483 | Length-100 cm | In distribution |
| 00884450100738 | Catheter Shape-SBS 3.5 (Mod) | In distribution |
| 00884450037508 | Catheter Shape-Judkins Right 5.0 | In distribution |
| 00884450036693 | Length-100 cm | In distribution |
| 00884450036785 | French Size (F)-6F | In distribution |
| 00884450242582 | Length-100 cm | In distribution |
| 00884450242797 | Internal Diameter-0.057″ (1.45 mm) | In distribution |
| 00884450036839 | Internal Diameter-0.070″ (1.78 mm) | In distribution |
| 00884450037218 | Internal Diameter-0.078″ (1.98 mm) | In distribution |
| 00884450036174 | Length-100 cm | In distribution |
| 00884450242612 | French Size (F)-8F | In distribution |
| 00884450036730 | Internal Diameter-0.070″ (1.78 mm) | In distribution |
| 00884450241561 | Internal Diameter-0.057″ (1.45 mm) | In distribution |
| 00884450036600 | French Size (F)-5F | In distribution |
| 00884450036754 | Length-100 cm | In distribution |
| 00884450037645 | Catheter Shape-Judkins Right 3.5 | In distribution |
| 00884450241684 | Internal Diameter-0.057″ (1.45 mm) | In distribution |
| 00884450037614 | French Size (F)-8F | In distribution |
| 00884450232156 | Length-100 cm | In distribution |
| 00884450037713 | Length-100 cm | In distribution |
| 00884450037164 | Internal Diameter-0.078″ (1.98 mm) | In distribution |
| 00884450246153 | Length-100 cm | In distribution |
| 00884450241547 | French Size (F)-5F | In distribution |
| 00884450241950 | Catheter Shape-SBSLAD 3.5 | In distribution |
| 00884450036648 | Internal Diameter-0.070″ (1.78 mm) | In distribution |
| 00884450036464 | Catheter Shape-Judkins Right 5.0 | In distribution |
| 00884450036457 | Internal Diameter-0.057″ (1.45 mm) | In distribution |
| 00884450037348 | Catheter Shape-Judkins Left 3.0 | In distribution |
| 00884450037553 | Length-100 cm | In distribution |
| 00884450036402 | Internal Diameter-0.057″ (1.45 mm) | In distribution |
| 00884450037676 | Internal Diameter-0.070″ (1.78 mm) | In distribution |
| 00884450036709 | Internal Diameter-0.070″ (1.78 mm) | In distribution |
| 00884450036594 | Length-100 cm | In distribution |
| 00884450036518 | Internal Diameter-0.057″ (1.45 mm) | In distribution |
| 00884450037492 | Length-100 cm | In distribution |
| 00884450036303 | French Size (F)-5F | In distribution |
| 00884450242506 | Internal Diameter-0.070″ (1.78 mm) | In distribution |
| 00884450037836 | Length-100 cm | In distribution |
| 00884450036334 | Length-100 cm | In distribution |
| 00884450037768 | French Size (F)-6F | In distribution |
| 00884450036921 | Internal Diameter-0.078″ (1.98 mm) | In distribution |
| 00884450036914 | Length-100 cm | In distribution |
| 00884450242810 | French Size (F)-6F | In distribution |
| 00884450232170 | Catheter Shape-Ultimate 4-T45 | In distribution |
| 00884450241943 | Catheter Shape-SBSLAD 3.0 | In distribution |
| 00884450037010 | Length-100 cm | In distribution |
| 00884450242629 | French Size (F)-8F | In distribution |
| 00884450036358 | French Size (F)-5F | In distribution |
| 00884450246115 | Internal Diameter-0.078″ (1.98 mm) | In distribution |
| 00884450123447 | French Size (F)-7F | In distribution |
| 00884450120231 | Catheter Shape-SBS 3.5 (Mod) | In distribution |
| 00884450123430 | Catheter Shape-Ultimate 2 | In distribution |
| 00884450036549 | Length-100 cm | In distribution |
| 00884450036433 | French Size (F)-5F | In distribution |
| 00884450037324 | Internal Diameter-0.088″ (2.24 mm) | In distribution |
| 00884450242650 | Length-100 cm | In distribution |
| 00884450242599 | Internal Diameter-0.088″ (2.24 mm) | In distribution |
| 00884450037195 | French Size (F)-7F | In distribution |
| 00884450036969 | Catheter Shape-Judkins Left 3.5 (Short Tip) | In distribution |
| 00884450037683 | Length-100 cm | In distribution |
| 00884450242834 | Length-100 cm | In distribution |
| 00884450036747 | Internal Diameter-0.070″ (1.78 mm) | In distribution |
| 00884450242681 | French Size (F)-8F | In distribution |
| 00884450037621 | Internal Diameter-0.088″ (2.24 mm) | In distribution |
| 00884450037775 | Internal Diameter-0.070″ (1.78 mm) | In distribution |
| 00884450037225 | French Size (F)-7F | In distribution |
| 00884450036716 | Length-100 cm | In distribution |
| 00884450096185 | Internal Diameter-0.070″ (1.78 mm) | In distribution |
| 00884450037522 | Catheter Shape-Left Coronary Bypass | In distribution |
| 00884450036235 | Catheter Shape-Amplatz Right 2 | In distribution |
| 00884450037447 | Internal Diameter-0.088″ (2.24 mm) | In distribution |
| 00884450248447 | French Size (F)-8F | In distribution |
Showing 250 of 295 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Launcher™ | Medtronic, Inc. | 3,805 |
| Sherpa NX Balanced™ | Medtronic, Inc. | 1,523 |
| Arrow | Teleflex Medical LLC | 1,249 |
| Z2 | Medtronic, Inc. | 955 |
| Vista Brite TIP | Cordis Corp. | 789 |
| Mach1™ | Boston Scientific Corporation | 777 |
| Sherpa NX Active | Medtronic, Inc. | 571 |
| Zuma® | Medtronic, Inc. | 569 |
| Convey | Pendracare International B.V. | 532 |
| Taiga | Medtronic, Inc. | 307 |
| RunWay™ | Boston Scientific Corporation | 300 |
| Wiseguide™ | Boston Scientific Corporation | 277 |
Showing 12 of 500. All products under Catheter, Percutaneous
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242873 | 2025-01-15 |
| K231246 | 2023-08-30 |
| K202610 | 2020-12-14 |
| K173548 | 2018-03-30 |
| K132409 | 2013-08-29 |
| K121051 | 2012-06-13 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2023-11-06 | Class II | Package design/selection | The sterility of microcatheter and infusion system devices cannot be guaranteed. | 59 units | |
| 2010-12-16 | Not classified | Packaging process control | Compromised sterility/weak or open seals. | 28,679 for all products | 2012-08-08 |
| 2004-10-15 | Not classified | Other | Merit Safety Paracentesis Procedure Trays contain Monoject Magellan safety needles which have been recalled by Tyco Healthcare.These needles may detach from their hub during use. | 2141 trays | 2004-12-15 |
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.