SureCross
25 catalogue numbers from 00884450168493, 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
25catalogue 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 | 2016-10-05 |
| Record revised | 2021-11-08 (version 4) |
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 |
| Packaging | Pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00884450168493 | Effective Length-135 cm | In distribution |
| 00884450187715 | Max. Guide Wire Diameter-0.035″ | In distribution |
| 00884450187692 | Min. Introducer Sheath-4F | In distribution |
| 00884450168486 | Max. Guide Wire Diameter-0.014″ | In distribution |
| C | Max. Guide Wire Diameter-0.014″ | In distribution |
| C | Max. Guide Wire Diameter-0.018″ | In distribution |
| 00884450187739 | Effective Length-90 cm | In distribution |
| D | Max. Guide Wire Diameter-0.018″ | In distribution |
| C | Effective Length-65 cm | In distribution |
| C | Hydrophilic Coating Length-40 cm | In distribution |
| 00884450168509 | Hydrophilic Coating Length-40 cm | In distribution |
| C | Effective Length-150 cm | In distribution |
| C | Effective Length-90 cm | In distribution |
| C | Max. Guide Wire Diameter-0.035″ | In distribution |
| 00884450168479 | Hydrophilic Coating Length-40 cm | In distribution |
| 00884450187753 | Max. Guide Wire Diameter-0.035″ | In distribution |
| 00884450187746 | Effective Length-135 cm | In distribution |
| 00884450168516 | Max. Guide Wire Diameter-0.018″ | In distribution |
| C | Min. Introducer Sheath-5F | In distribution |
| 00884450187623 | Hydrophilic Coating Length-40 cm | In distribution |
| 00884450187630 | Hydrophilic Coating Length-40 cm | In distribution |
| C | Min. Introducer Sheath-5F | In distribution |
| C | Hydrophilic Coating Length-40 cm | In distribution |
| D | Max. Guide Wire Diameter-0.014″ | In distribution |
| D | Hydrophilic Coating Length-40 cm | In distribution |
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 |
| ConcierGE Guiding Excellence™ | Merit Medical Systems, Inc. | 295 |
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.