Nanostim™
The listed Nanostim Introducer Kit is the device named in the FDA filing. The filing describes it as a guiding sheath for introducing diagnostic and interventional devices. Its stated use…
The listed Nanostim Introducer Kit is the device named in the FDA filing. The filing describes it as a guiding sheath for introducing diagnostic and interventional devices.
Its stated use is to provide a conduit into the venous system for insertion of diagnostic and other interventional devices.
Listed Item
18F Nanostim Introducer, 30cm
Kit Design
The kit contains an introducer sheath and dilator. The filing says it is available in 18F with 30 cm and 50 cm lengths.
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) | K161102 |
| Record published | 2018-03-21 |
| Record revised | 2024-03-20 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep in a cool, dry place. Do not expose to sunlight. Do not drop. Do not use if package is damaged. |
| Packaging | Pack of 5 |
| Sizes | Catheter gauge 18 Fr; length 11.8 to 19.7 in; length 30 to 50 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Introducer Kit | Inner Diameter | In distribution |
| Introducer Kit | 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
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.