Solo-Trak®-KR
Introducer 6209BTKL1S Lead SGL PK SGL CH
13manufacturers in China registered for this device type
30catalogue numbers in this listing
3510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (5), Beijing (3), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Tianjin Demax Medical Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Beijing Demax Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Tianjin Ethylene Oxide Sterilization Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 4 |
| Shanghai Microport EP Medtech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
| Becton Dickinson Medical Devices Co., Ltd. Suzhou | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Cardiocycle Medical(Suzhou) Co., Ltd. | Suzhou | Jiangsu | Complaint-file establishment | 1 |
Showing 12 of 13. All 13 manufacturers in China registered for Introducer, Catheter
Record
| Listed by | Medtronic, Inc., United States |
|---|---|
| FDA product code | DYB |
| Device type | Introducer, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1340 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K965167 |
| Record published | 2017-01-03 |
| Record revised | 2024-03-20 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Storage | Storage environment temperature up to 104 °F |
| Packaging | Pack of 5 |
| Distribution end date | 2022-08-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6207BTKL1 | Introducer inner diameter 7 French | In distribution |
| 6207BTK-5 | Introducer inner diameter 7 French | In distribution |
| 6207BTKL1S | Introducer inner diameter 7 French | Withdrawn |
| 6209BTKL1S | Introducer inner diameter 9 French | Withdrawn |
| 6209BTK1S | Introducer inner diameter 9 French | Withdrawn |
| 6210BTK-5 | Introducer inner diameter 10.5 French | Withdrawn |
| 6210BTKL1 | Introducer inner diameter 10.5 French | Withdrawn |
| 6212BTK-5 | Introducer inner diameter 12 French | Withdrawn |
| 6207BTK-D1 | Introducer inner diameter 7 French | Withdrawn |
| 6211BTK5 | Introducer inner diameter 11 French | Withdrawn |
| 6208BTK-D1 | Introducer inner diameter 8 French | Withdrawn |
| 6210BTK5S | Introducer inner diameter 10.5 French | Withdrawn |
| 6208BTK5S | Introducer inner diameter 8 French | Withdrawn |
| 6210BTK-1 | Introducer inner diameter 10.5 French | Withdrawn |
| 6209BTK-5 | Introducer inner diameter 9 French | Withdrawn |
| 6208BTK-1 | Introducer inner diameter 8 French | Withdrawn |
| 6207BTK-1 | Introducer inner diameter 7 French | Withdrawn |
| 6208BTK1S | Introducer inner diameter 8 French | Withdrawn |
| 6208BTKL1 | Introducer inner diameter 8 French | Withdrawn |
| 6209BTK-1 | Introducer inner diameter 9 French | Withdrawn |
| 6210BTKL1S | Introducer inner diameter 10.5 French | Withdrawn |
| 6210BTK-D1 | Introducer inner diameter 10.5 French | Withdrawn |
| 6209BTK5S | Introducer inner diameter 9 French | Withdrawn |
| 6208BTKL1S | Introducer inner diameter 8 French | Withdrawn |
| 6207BTK5S | Introducer inner diameter 7 French | Withdrawn |
| 6207BTK1S | Introducer inner diameter 7 French | Withdrawn |
| 6209BTKL1 | Introducer inner diameter 9 French | Withdrawn |
| 6208BTK5 | Introducer inner diameter 8 French | Withdrawn |
| 6209BTK-D1 | Introducer inner diameter 9 French | Withdrawn |
| 6211BTK-1 | Introducer inner diameter 11 French | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Demax | Beijing Demax Medical Technology Co., Ltd. | 2,841 |
| Arrow | Teleflex Medical LLC | 1,036 |
| Prelude IDeal™ | Merit Medical Systems, Inc. | 294 |
| Fast-Cath™ | St. Jude Medical | 213 |
| Flexor | Cook Incorporated | 182 |
| Prelude Ease™ | Merit Medical Systems, Inc. | 176 |
| Performer | Cook Incorporated | 174 |
| VSI | Teleflex Medical LLC | 154 |
| Peel-Away | Cook Incorporated | 153 |
| OptiSeal™ | Greatbatch Medical | 127 |
| Brilliant | Lepu Medical Technology (Beijing) Co., Ltd. | 122 |
| Super Sheath | Togo Medikit Co., Ltd. | 122 |
Showing 12 of 439. All products under Introducer, Catheter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152054 | 2015-08-07 |
| K132617 | 2014-04-30 |
| K132030 | 2013-09-27 |
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 |
|---|---|---|---|---|---|
| 2015-02-23 | Class I | Nonconforming Material/Component | Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the Steerable Sheath, outside of the patients bodies. | 151 (4 US, 147 OUS) | 2015-10-07 |
| 2013-07-08 | Class II | Packaging change control | Medtronic identified a specific labeling issue for specific lots of Mullins Transseptal Catheter Introducer Sheath, model 008551, in which packages labeled as Mullins 7F (French) may actually contain an 8F(French) dilator. Medtronic is req | 269 | 2014-03-06 |
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.