Attain Select™ II + SureValve™
Attain Select II + SureValve is a delivery catheter system for guiding left-heart leads to a desired cardiac vein. It delivers contrast medium and transvenous devices into the coronary…
Attain Select II + SureValve is a delivery catheter system for guiding left-heart leads to a desired cardiac vein. It delivers contrast medium and transvenous devices into the coronary sinus and left-heart venous anatomy.
The system combines a delivery catheter with an integrated SureValve hemostasis valve, an inner catheter and up to two valve tools. It is used with an outer guide catheter.
Listed Item
Catheter 6248V-130L Attain Select II US
Telescoping Access
The inner delivery system and outer guide catheter work together as a telescoping assembly, providing additional ability to select venous branches. Multiple models, including 6248V-130, provide catheter configurations within the Attain Select II family.
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) | K192712 |
| Record published | 2020-10-29 |
| Record revised | 2021-12-22 (version 7) |
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 | Storage environment temperature up to 40 °C; Storage environment temperature up to 104 °F |
| Sizes | Catheter working length 57 to 65 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6248V-90P | Catheter outer diameter 2.4 mm (7.1 Fr) | In distribution |
| 6248V-130 | Catheter inner diameter 1.9 mm (5.7 Fr) | In distribution |
| 6248V-90S | Catheter inner diameter 1.9 mm (5.7 Fr) | In distribution |
| 6248V-130L | Catheter outer diameter 2.4 mm (7.1 Fr) | In distribution |
| 6248V-130P | Catheter outer diameter 2.4 mm (7.1 Fr) | In distribution |
| 6248V-90P | Catheter inner diameter 1.9 mm (5.7 Fr) | In distribution |
| 6248V-130L | Catheter outer diameter 2.4 mm (7.1 Fr) | In distribution |
| 6248V-90 | Catheter length 65 cm | In distribution |
| 6248V-90S | Catheter length 65 cm | In distribution |
| 6248V-90 | Catheter inner diameter 1.9 mm (5.7 Fr) | In distribution |
| 6248V-90SP | Catheter outer diameter 2.4 mm (7.1 Fr) | In distribution |
| 6248V-130P | Catheter length 57 cm | In distribution |
| 6248V-90SP | Catheter Working Length 57.0 cm | In distribution |
| 6248V-90L | Catheter inner diameter 1.9 mm (5.7 Fr) | In distribution |
| 6248V-90P | Catheter outer diameter 2.4 mm (7.1 Fr) | In distribution |
| 6248V-130 | Catheter Working Length 65.0 cm | In distribution |
| 6248V-90L | Catheter outer diameter 2.4 mm (7.1 Fr) | In distribution |
| 6248V-130L | Catheter outer diameter 2.4 mm (7.1 Fr) | In distribution |
| 6248V-90S | Catheter inner diameter 1.9 mm (5.7 Fr) | In distribution |
| 6248V-90 | Catheter outer diameter 2.4 mm (7.1 Fr) | In distribution |
| 6248V-90SP | Catheter length 57 cm | In distribution |
| 6248V-130P | Catheter inner diameter 1.9 mm (5.7 Fr) | In distribution |
| 6248V-90L | Catheter length 65 cm | In distribution |
| 6248V-130 | Catheter length 65 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 |
|---|---|
| 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
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.