Dorado®
Dorado® PTA Balloon Dilatation Catheter 6 mm x 170 mm, 135 cm Catheter
14manufacturers in China registered for this device type
47catalogue numbers in this listing
5510(k) clearances naming this product code
23recalls 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 | Bard Peripheral Vascular, Inc., 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 |
| Record published | 2016-08-08 |
| Record revised | 2024-04-17 (version 4) |
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 |
| Distribution end date | 2022-10-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DR4064 | Balloon length, 40 Millimeters | In distribution |
| DR13558 | Balloon length, 80 Millimeters | In distribution |
| DR4082 | Balloon diameter, 8 Millimeters | In distribution |
| DR12084 | Catheter shaft length, 120 Centimeters | In distribution |
| DR13584 | Balloon diameter, 8 Millimeters | In distribution |
| DR8084 | Catheter shaft length, 80 Centimeters | In distribution |
| DR80510 | Balloon length, 100 Millimeters | In distribution |
| DR8088 | Balloon length, 80 Millimeters | In distribution |
| DR8058 | Catheter shaft length, 80 Centimeters | In distribution |
| DR135617 | Catheter shaft length, 135 Centimeters | In distribution |
| DR8098 | Balloon length, 80 Millimeters | In distribution |
| DR120104 | Balloon length, 40 Millimeters | In distribution |
| DR12074 | Balloon diameter, 7 Millimeters | In distribution |
| DR8062 | Balloon diameter, 6 Millimeters | In distribution |
| DR120710 | Balloon length, 100 Millimeters | In distribution |
| DR8056 | Balloon diameter, 5 Millimeters | In distribution |
| DR12054 | Balloon length, 40 Millimeters | In distribution |
| DR8074 | Catheter shaft length, 80 Centimeters | In distribution |
| DR8053 | Balloon diameter, 5 Millimeters | In distribution |
| DR4062 | Balloon length, 20 Millimeters | In distribution |
| DR8032 | Balloon length, 20 Millimeters | In distribution |
| DR80715 | Balloon diameter, 7 Millimeters | In distribution |
| DR12064 | Balloon length, 40 Millimeters | In distribution |
| DR135412 | Balloon length, 120 Millimeters | In distribution |
| DR80612 | Catheter shaft length, 80 Centimeters | In distribution |
| DR135510 | Balloon length, 100 Millimeters | In distribution |
| DR135420 | Balloon diameter, 4 Millimeters | In distribution |
| DR135517 | Catheter shaft length, 135 Centimeters | In distribution |
| DR13588 | Balloon length, 80 Millimeters | In distribution |
| DR8064 | Balloon diameter, 6 Millimeters | In distribution |
| DR80102 | Catheter shaft length, 80 Centimeters | In distribution |
| DR13594 | Balloon diameter, 9 Millimeters | In distribution |
| DR80810 | Balloon length, 100 Millimeters | In distribution |
| DR135410 | Balloon diameter, 4 Millimeters | In distribution |
| DR135717 | Balloon length, 170 Millimeters | In distribution |
| DR4044 | Catheter shaft length, 40 Centimeters | In distribution |
| DR8092 | Balloon length, 20 Millimeters | In distribution |
| DR120610 | Balloon diameter, 6 Millimeters | In distribution |
| DR135712 | Balloon length, 120 Millimeters | In distribution |
| DR8082 | Balloon length, 20 Millimeters | In distribution |
| DR13582 | Balloon diameter, 8 Millimeters | In distribution |
| DR8052 | Catheter shaft length, 80 Centimeters | In distribution |
| DR80103 | Catheter shaft length, 80 Centimeters | In distribution |
| DR8054 | Balloon length, 40 Millimeters | In distribution |
| DR8086 | Balloon diameter, 8 Millimeters | In distribution |
| DR120810 | Balloon diameter, 8 Millimeters | Withdrawn |
| DR12034 | Catheter shaft length, 120 Centimeters | 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 |
|---|---|
| K250219 | 2025-06-17 |
| K161986 | 2016-08-04 |
| K103367 | 2010-12-08 |
| K072283 | 2007-09-19 |
| K052236 | 2005-08-23 |
Recalls
7 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 |
|---|---|---|---|---|---|
| 2020-10-01 | Class II | Labeling Change Control | Dilation catheter packaged with the wrong size balloon. The labeling states that the balloon size is 6mm x 40mm, however included is a 5mm x 40mm balloon. Use of a balloon that has a smaller diameter than expected could result in inconseq | 281 units | 2022-05-25 |
| 2018-04-16 | Class II | Process control | Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. The bacterial endotoxin levels for the catheters are within acceptable levels; however, if bacterial endoto | 130 units | 2021-03-02 |
| 2018-04-16 | Class II | Process control | Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. The bacterial endotoxin levels for the catheters are within acceptable levels; however, if bacterial endoto | 140 units | 2021-03-02 |
| 2015-03-23 | Class II | Process control | Bard Peripheral Vascular is recalling the Bard ConQuest PTA Balloon Dilatation Catheter because it may be at risk of having deflation related issues. | 2620 units | 2015-08-28 |
| 2013-05-28 | Class II | Mixed-up of materials/components | Bard Peripheral Vascular (BPV) has confirmed that some product code/lot number combination of devices may have the incorrect balloon diameter labeled on the inflation hub. Specifically, the balloon size printed on the hub may read 7mm x 4cm | 415 | 2013-10-23 |
| 2013-01-23 | Class II | Process control | Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard UltraClip Dual Trigger Tissue Marker’s and support catheters (Microsheath and Usher) were inadvertently distributed to customers without completing the s | 17 | 2013-06-10 |
| 2013-01-23 | Class II | Process control | Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard UltraClip Dual Trigger Tissue Marker’s and support catheters (Microsheath and Usher) were inadvertently distributed to customers without completing the s | 223 | 2013-06-10 |
| 2010-05-04 | Not classified | Nonconforming Material/Component | The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft. | 213 | 2012-02-01 |
| 2010-05-04 | Not classified | Nonconforming Material/Component | The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft. | 194 units | 2012-02-01 |
| 2010-05-04 | Not classified | Nonconforming Material/Component | The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft. | 212 units | 2012-02-01 |
| 2010-05-04 | Not classified | Nonconforming Material/Component | The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft. | 135 units | 2012-02-01 |
| 2010-05-04 | Not classified | Nonconforming Material/Component | The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft. | 46 units | 2012-02-01 |
| 2010-05-04 | Not classified | Nonconforming Material/Component | The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft. | 207 | 2012-02-01 |
| 2010-05-04 | Not classified | Nonconforming Material/Component | The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft. | 522 units | 2012-02-01 |
| 2010-05-04 | Not classified | Nonconforming Material/Component | The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft. | 449 units | 2012-02-01 |
| 2010-05-04 | Not classified | Nonconforming Material/Component | The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft. | 72 units | 2012-02-01 |
| 2010-05-04 | Not classified | Nonconforming Material/Component | The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft. | 250 units | 2012-02-01 |
| 2010-05-04 | Not classified | Nonconforming Material/Component | The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft. | 56 units | 2012-02-01 |
| 2010-05-04 | Not classified | Nonconforming Material/Component | The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft. | 227 units | 2012-02-01 |
| 2010-05-04 | Not classified | Nonconforming Material/Component | The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft. | 96 units | 2012-02-01 |
| 2010-05-04 | Not classified | Nonconforming Material/Component | The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft. | 406 units | 2012-02-01 |
| 2010-05-04 | Not classified | Nonconforming Material/Component | The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft. | 194 units | 2012-02-01 |
| 2003-09-18 | Not classified | Other | Mislabeled. 7mm balloon labeled 12mm | 124 | 2004-12-10 |
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.