Opta
Opta PRO F5 7X10 110 CM
14manufacturers in China registered for this device type
74catalogue numbers in this listing
1510(k) clearance
5recalls 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 | Cordis US Corp., United States |
|---|---|
| FDA product code | DQY |
| Device type | Catheter, Percutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K032737 |
| Record published | 2016-08-01 |
| Record revised | 2025-09-05 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C |
| Distribution end date | 2024-07-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4198040X | In distribution | |
| 4194020X | In distribution | |
| 4198040L | In distribution | |
| 4198020X | In distribution | |
| 4196020S | In distribution | |
| 4195040S | In distribution | |
| 4197040S | In distribution | |
| 4198080S | In distribution | |
| 4192020L | In distribution | |
| 4193040S | In distribution | |
| 4199010S | In distribution | |
| 4194020S | In distribution | |
| 4195080L | In distribution | |
| 4195020S | In distribution | |
| 4198030L | In distribution | |
| 4198015S | In distribution | |
| 4197040L | In distribution | |
| 4194000S | In distribution | |
| 4198080L | In distribution | |
| 4197030L | In distribution | |
| 4197060L | In distribution | |
| 4199040L | In distribution | |
| 4196060L | In distribution | |
| 4197000L | In distribution | |
| 4196000L | In distribution | |
| 4199080S | In distribution | |
| 4196020L | In distribution | |
| 4197040X | In distribution | |
| 4195040X | In distribution | |
| 4190040X | In distribution | |
| 4194040S | In distribution | |
| 4199020L | In distribution | |
| 4196040L | In distribution | |
| 4195000L | In distribution | |
| 4194010S | In distribution | |
| 4190020L | In distribution | |
| 4198060S | In distribution | |
| 4190040S | In distribution | |
| 4199000S | In distribution | |
| 4195015S | In distribution | |
| 4196080S | In distribution | |
| 4193040L | In distribution | |
| 4190040L | In distribution | |
| 4192030S | In distribution | |
| 4194080S | In distribution | |
| 4196010S | In distribution | |
| 4190080S | In distribution | |
| 4196040X | In distribution | |
| 4196040S | In distribution | |
| 4197015S | In distribution | |
| 4190030S | In distribution | |
| 4198040S | In distribution | |
| 4194000L | In distribution | |
| 4197000S | In distribution | |
| 4197020L | In distribution | |
| 4190020S | In distribution | |
| 4197010S | In distribution | |
| 4193080L | In distribution | |
| 4192020S | In distribution | |
| 4198030S | In distribution | |
| 4196060S | In distribution | |
| 4196015S | In distribution | |
| 4190000S | In distribution | |
| 4190060S | In distribution | |
| 4195020X | In distribution | |
| 4198000L | In distribution | |
| 4195010S | In distribution | |
| 4192040L | In distribution | |
| 4194080L | In distribution | |
| 4192040S | In distribution | |
| 4194040X | In distribution | |
| 4198020L | In distribution | |
| 4195000S | Withdrawn | |
| 4198000S | Withdrawn |
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 |
|---|---|
| K233637 | 2024-06-28 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Cordis US Corp. | 510(k) number | 2020-01-08 | Class II | Pending | Cordis is recalling one (1) lot of POWERFLEX P3 PTA Dilatation Catheter due to the potential for body/shaft voids in the proximal seal area. | 89 units | 2023-01-13 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-02-07 | Class II | Employee error | Catheter manufactured at the incorrect length. | 12 units | |
| 2019-02-07 | Class III | Equipment maintenance | Frayed pieces of the mounting card being inside the primary packaging. | 23481 | 2021-11-03 |
| 2013-08-12 | Class II | Error in labeling | Due to a labeling error related to the conversion of the inner diameter of the catheter from inches to millimeters. The English dimension is correct and is the primary dimension. | 1238 units | 2014-09-30 |
| 2004-12-07 | Not classified | Other | Two complaints have been received and confirmed, regarding a lot, indicating that the distal end had an ‘RDC’ shape rather than the ‘RDC(1)’ shape. The RDC shape has a larger curve. The product was manufactured with the incorrect forming w | 153 units | 2008-11-19 |
| 2004-05-05 | Not classified | Other | The product is labeled as Straight Catheter but the package contains Contralateral Guide shaped Catheters. | 40 | 2008-11-21 |
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.