Agilis™
NxT Steerable Introducer
13manufacturers in China registered for this device type
13catalogue numbers in this listing
26510(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 | St. Jude Medical, United States |
|---|---|
| FDA product code | DYB |
| Device type | Introducer, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1340 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K061363 |
| Record published | 2015-03-06 |
| Record revised | 2023-07-31 (version 9) |
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, expiry date |
| Storage | Special storage condition: Keep dry, Keep away from sunlight, Protect from heat and radioactive sources |
| Sizes | Catheter gauge 8.5 Fr; length 40 to 82 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G408319 | Catheter Gauge 8.5 Fr | In distribution |
| G408320 | Catheter Gauge 8.5 Fr | In distribution |
| 408313 | Catheter Gauge 8.5 Fr | In distribution |
| 408315 | Catheter Gauge 8.5 Fr | In distribution |
| G408318 | Catheter Gauge 8.5 Fr | In distribution |
| G408332 | Catheter Gauge 8.5 Fr | In distribution |
| G408324 | Catheter Gauge 8.5 Fr | In distribution |
| 408310 | Catheter Gauge 8.5 Fr | In distribution |
| 408309 | Catheter Gauge 8.5 Fr | In distribution |
| G408321 | Catheter Gauge 8.5 Fr | In distribution |
| G402049 | Catheter Gauge 8.5 Fr | In distribution |
| 408314 | Catheter Gauge 8.5 Fr | In distribution |
| 408312 | Catheter Gauge 8.5 Fr | In distribution |
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 |
|---|---|
| K161102 | 2016-05-19 |
| K160716 | 2016-04-14 |
| K140793 | 2014-12-17 |
| K140327 | 2014-03-11 |
| K111092 | 2011-06-09 |
| K110450 | 2011-05-10 |
| K103083 | 2011-04-08 |
| K101883 | 2010-09-07 |
| K093130 | 2009-11-04 |
| K092575 | 2009-10-08 |
| K091137 | 2009-04-22 |
| K083402 | 2008-12-15 |
| K081645 | 2008-12-09 |
| K083083 | 2008-11-06 |
| K070417 | 2007-06-05 |
| K070166 | 2007-04-06 |
| K061015 | 2006-08-03 |
| K061363 | 2006-07-12 |
| K052644 | 2005-12-05 |
| K031906 | 2003-07-18 |
| K023447 | 2002-10-31 |
| K013029 | 2001-10-09 |
| K012922 | 2001-09-25 |
| K003729 | 2001-01-03 |
| K001367 | 2000-05-31 |
| K001346 | 2000-05-24 |
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 |
|---|---|---|---|---|---|---|
| St. Jude Medical, Atrial Fibrillation Division, Inc. | 510(k) number | 2024-04-30 | Class II | Under Investigation by firm | One lot of product has dilators that are too short and will not extend outside the introducer sheath. | 129 units |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-10-14 | Class II | Process control | St. Jude Medical is conducting a voluntary recall of SMJ Batch # 4641580 of the Fast-Cath Trio” Hemostasis Introducer, Catalog number 406308. The inner diameter of the 10F dilator is too small, such that the guidewire cannot advance through | 220 | 2015-03-25 |
| 2012-03-28 | Class III | Process control | St. Jude Medical is recalling a single batch of Fast Cath Transseptal Guiding Introducers which was packaged as a 180 degree curve style introducer instead of a 90 degree curve style introducer as indicated on the labeling. | 26 | 2013-07-12 |
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.