Pacific Xtreme
Cath PCU040200130 PCU US 04.00L200UL1300
14manufacturers in China registered for this device type
55catalogue numbers in this listing
15510(k) clearances naming this product code
7recalls 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 | Medtronic, Inc., United States |
|---|---|
| FDA product code | DQY |
| Device type | Catheter, Percutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K103464 |
| Record published | 2016-04-30 |
| Record revised | 2020-07-20 (version 5) |
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 |
| Storage | Special storage condition: Store at controlled room temperature, in a dry place. Do not expose to organic solvents (e.g. alcohol), ionizing radiati |
| Sizes | Length 150 to 300 mm; outer diameter 4 to 7 mm |
| Distribution end date | 2024-05-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PCU040200130 | Length 200.0 mm | In distribution |
| PCU070250130 | Balloon Length 250 MM | In distribution |
| PCU040200130 | Balloon Diameter 4 MM | In distribution |
| PCU050250130 | Balloon Length 250 MM | In distribution |
| PCU050150090 | Length 150.0 mm | In distribution |
| PCU040300090 | Length 300.0 mm | In distribution |
| PCU040200090 | Outer Diameter 4.0 mm | In distribution |
| PCU070150090 | Length 150.0 mm | In distribution |
| PCU040200130 | Outer Diameter 4.0 mm | In distribution |
| PCU070250130 | Length 250.0 mm | In distribution |
| PCU070150130 | Outer Diameter 7.0 mm | In distribution |
| PCU060250090 | Balloon Length 250 MM | In distribution |
| PCU040150090 | Length 150.0 mm | In distribution |
| PCU070200130 | Length 200.0 mm | In distribution |
| PCU070150090 | Outer Diameter 7.0 mm | In distribution |
| PCU050300130 | Balloon Length 300 MM | In distribution |
| PCU050200130 | Balloon Length 200 MM | In distribution |
| PCU050150130 | Balloon Length 150 MM | In distribution |
| PCU050300090 | Balloon Length 300 MM | In distribution |
| PCU040250130 | Length 250.0 mm | In distribution |
| PCU060250130 | Outer Diameter 6.0 mm | In distribution |
| PCU070200090 | Outer Diameter 7.0 mm | In distribution |
| PCU060200130 | Balloon Diameter 6 MM | In distribution |
| PCU050150130 | Outer Diameter 5.0 mm | In distribution |
| PCU070250090 | Outer Diameter 7.0 mm | In distribution |
| PCU040300130 | Outer Diameter 4.0 mm | In distribution |
| PCU060300130 | Length 300.0 mm | In distribution |
| PCU050200130 | Outer Diameter 5.0 mm | In distribution |
| PCU050150090 | Outer Diameter 5.0 mm | In distribution |
| PCU060250130 | Outer Diameter 6.0 mm | In distribution |
| PCU040200130 | Outer Diameter 4.0 mm | In distribution |
| PCU050250130 | Length 250.0 mm | In distribution |
| PCU040250090 | Length 250.0 mm | In distribution |
| PCU050250130 | Outer Diameter 5.0 mm | In distribution |
| PCU070200130 | Outer Diameter 7.0 mm | In distribution |
| PCU070150130 | Balloon Length 150 MM | In distribution |
| PCU070200130 | Outer Diameter 7.0 mm | In distribution |
| PCU050250090 | Outer Diameter 5.0 mm | In distribution |
| PCU060150130 | Balloon Diameter 6 MM | In distribution |
| PCU060300090 | Length 300.0 mm | In distribution |
| PCU040300090 | Balloon Length 300 MM | In distribution |
| PCU050200090 | Length 200.0 mm | In distribution |
| PCU070250090 | Balloon Length 250 MM | In distribution |
| PCU070200090 | Balloon Length 200 MM | In distribution |
| PCU050200090 | Length 200.0 mm | In distribution |
| PCU040200090 | Balloon Length 200 MM | In distribution |
| PCU070250090 | Length 250.0 mm | In distribution |
| PCU040150130 | Length 150.0 mm | In distribution |
| PCU040300090 | Outer Diameter 4.0 mm | In distribution |
| PCU060150090 | Length 150.0 mm | In distribution |
| PCU040150090 | Length 150.0 mm | Withdrawn |
| PCU040150090 | Length 150.0 mm | Withdrawn |
| PCU060200090 | Length 200.0 mm | Withdrawn |
| PCU060250090 | Outer Diameter 6.0 mm | Withdrawn |
| PCU060300130 | Length 300.0 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 |
|---|---|
| K253409 | 2025-12-19 |
| K250558 | 2025-03-27 |
| K223178 | 2022-11-08 |
| K222873 | 2022-11-07 |
| K192712 | 2020-08-03 |
| K183353 | 2019-03-22 |
| K183493 | 2019-03-15 |
| K132673 | 2013-10-22 |
| K121219 | 2012-09-25 |
| K112917 | 2011-10-27 |
| K103386 | 2011-02-11 |
| K101885 | 2010-09-09 |
| K090659 | 2009-03-26 |
| K080428 | 2008-12-09 |
| K082670 | 2008-12-04 |
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 |
|---|---|---|---|---|---|---|---|
| ev3, Inc. | 510(k) number | 2020-08-26 | Class II | Under Investigation by firm | Labeling discrepancy for the Rated Burst Pressure (RBP) value. | 4286 devices | 2023-06-09 |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. 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 |
|---|---|---|---|---|---|
| 2022-04-20 | Class II | Under Investigation by firm | The firm’s internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility. | 1385 devices | |
| 2021-09-09 | Class II | Under Investigation by firm | Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter. | 591 units | |
| 2017-09-26 | Class I | Nonconforming Material/Component | Complaints regarding 6F Taiga guide catheter tip detachment and/or tip splitting. | 15,923 | 2021-04-27 |
| 2013-06-12 | Class II | Labeling mix-ups | Medtronic has identified a labeling issue for 24 units of the Launcher coronary Guide Catheter. The two affected catheter lots are mislabeled and do not accurately reflect the catheters contained within each package. | 15 | 2013-11-19 |
| 2008-08-27 | Not classified | Process control | Medtronic has identified an issue with the packaging for specific lots of the Medtronic Adjustable Valve and valves contained in the Attain Left Heart Delivery System kits. A small number of valve package seals could be compromised. | 35,193 total | 2011-05-07 |
| 2008-08-27 | Not classified | Process control | Medtronic has identified an issue with the packaging for specific lots of the Medtronic Adjustable Valve and valves contained in the Attain Left Heart Delivery System kits. A small number of valve package seals could be compromised. | 35,193 total | 2011-05-07 |
| 2002-11-25 | Not classified | Other | An RF pulse occurs each time the temperature set point increase button is activated while ablating and this can result in heart rhythm disturbances. | 775 units | 2003-11-04 |
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.