Passeo-35
52 catalogue numbers from 7/60/130, listed by Biotronik, Inc., United States, under Catheter, Percutaneous. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
52catalogue numbers in this listing
23510(k) clearances naming this product 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 | Biotronik, Inc., United States |
|---|---|
| FDA product code | DQY |
| Device type | Catheter, Percutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K082933 |
| Record published | 2016-08-30 |
| Record revised | 2026-05-29 (version 8) |
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 |
| Storage | Storage environment temperature 50 to 104 °F; Storage environment temperature 10 to 40 °C; Special storage condition: Keep dry Keep away from sunlight |
| Distribution end date | 2025-03-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7/60/130 | Diameter: 7 mm | Withdrawn |
| 6/80/130 | Length: 80 mm | Withdrawn |
| 3/40/130 | Length: 40 mm | Withdrawn |
| 4/20/80 | Diameter: 4 mm | Withdrawn |
| 7/100/130 | Diameter: 7 mm | Withdrawn |
| 6/80/80 | Usable Length: 80 cm | Withdrawn |
| 7/40/130 | Length: 40 mm | Withdrawn |
| 4/40/130 | Usable Length: 130 cm | Withdrawn |
| 4/20/130 | Usable Length: 130 cm | Withdrawn |
| 3/20/130 | Usable Length: 130 cm | Withdrawn |
| 7/20/80 | Length: 20 mm | Withdrawn |
| 7/60/80 | Usable Length: 80 cm | Withdrawn |
| 3/20/80 | Length: 20 mm | Withdrawn |
| 7/100/80 | Length: 100 mm | Withdrawn |
| 10/20/80 | Usable Length: 80 cm | Withdrawn |
| 5/20/130 | Usable Length: 130 cm | Withdrawn |
| 6/40/80 | Diameter: 6 mm | Withdrawn |
| 8/40/80 | Usable Length: 80 cm | Withdrawn |
| 9/40/80 | Usable Length: 80 cm | Withdrawn |
| 8/100/80 | Usable Length: 80 cm | Withdrawn |
| 8/100/130 | Diameter: 8 mm | Withdrawn |
| 6/100/80 | Usable Length: 80 cm | Withdrawn |
| 5/40/80 | Length: 40 mm | Withdrawn |
| 9/20/80 | Diameter: 9 mm | Withdrawn |
| 6/20/80 | Length: 20 mm | Withdrawn |
| 8/40/130 | Diameter: 8 mm | Withdrawn |
| 5/80/130 | Usable Length: 130 cm | Withdrawn |
| 8/60/80 | Usable Length: 80 cm | Withdrawn |
| 6/20/130 | Usable Length: 130 cm | Withdrawn |
| 10/40/80 | Diameter: 10 mm | Withdrawn |
| 5/80/80 | Length: 80 mm | Withdrawn |
| 5/100/80 | Usable Length: 80 cm | Withdrawn |
| 7/80/130 | Diameter: 7 mm | Withdrawn |
| 5/60/80 | Length: 60 mm | Withdrawn |
| 6/60/130 | Length: 60 mm | Withdrawn |
| 7/80/80 | Length: 80 mm | Withdrawn |
| 3/40/80 | Diameter: 3 mm | Withdrawn |
| 5/60/130 | Diameter: 5 mm | Withdrawn |
| 8/20/80 | Length: 20 mm | Withdrawn |
| 5/40/130 | Length: 40 mm | Withdrawn |
| 6/60/80 | Usable Length: 80 cm | Withdrawn |
| 8/80/130 | Length: 80 mm | Withdrawn |
| 6/100/130 | Usable Length: 130 cm | Withdrawn |
| 6/40/130 | Usable Length: 130 cm | Withdrawn |
| 4/40/80 | Length: 40 mm | Withdrawn |
| 8/20/130 | Usable Length: 130 cm | Withdrawn |
| 5/20/80 | Diameter: 5 mm | Withdrawn |
| 5/100/130 | Length: 100 mm | Withdrawn |
| 8/60/130 | Length: 60 mm | Withdrawn |
| 7/40/80 | Usable Length: 80 cm | Withdrawn |
| 8/80/80 | Length: 80 mm | Withdrawn |
| 7/20/130 | Diameter: 7 mm | 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 |
|---|---|
| K240787 | 2024-09-12 |
| K222037 | 2022-07-19 |
| K193474 | 2020-10-16 |
| K192996 | 2019-11-21 |
| K183265 | 2018-12-13 |
| K151409 | 2015-08-07 |
| K131978 | 2013-08-23 |
| K123324 | 2013-01-11 |
| K112482 | 2011-09-26 |
| K111839 | 2011-09-26 |
| K111154 | 2011-05-23 |
| K110461 | 2011-04-20 |
| K101776 | 2010-07-23 |
| K101282 | 2010-07-21 |
| K093303 | 2009-11-20 |
| K082933 | 2008-11-03 |
| K080988 | 2008-05-07 |
| K072329 | 2008-03-25 |
| K071665 | 2007-07-18 |
| K060807 | 2006-04-24 |
| K060655 | 2006-04-04 |
| K033320 | 2003-11-19 |
| K033217 | 2003-10-31 |
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.