Palmaz Genesis Transhepatic Biliary Stent on SLALOM.018″ Delivery System
Shrt Gen on SL 18 X 50 BIL 80
6manufacturers in China registered for this device type
26catalogue numbers in this listing
15recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 19 |
| Dongguan TT Medical, Inc. | Dongguan | Guangdong | Manufacturer | 4 |
| LEO Medical Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Cordis US Corp., United States |
|---|---|
| FDA product code | FGE |
| Device type | Stents, Drains And Dilators For The Biliary Ducts |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5010 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K021345 |
| Record published | 2015-08-28 |
| Record revised | 2025-09-05 (version 8) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| 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: Store in a cool, dark, dry place.; Special storage condition: Do not use open or damaged packages |
| Packaging | Box |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PG2430BSS | In distribution | |
| PG1830BSS | In distribution | |
| PG2470BSX | In distribution | |
| PG1850BSS | In distribution | |
| PG1230BSS | In distribution | |
| PG1830BSX | In distribution | |
| PG1530BSS | In distribution | |
| PG2590BPS | In distribution | |
| PG1560BSS | In distribution | |
| PG1230BSX | In distribution | |
| PG1540BSS | In distribution | |
| PG3950BSS | In distribution | |
| PG2440BSS | In distribution | |
| PG1840BSS | In distribution | |
| PG3970BSS | In distribution | |
| PG3980BSS | In distribution | |
| PG1240BSS | In distribution | |
| PG2970BSX | In distribution | |
| PG3960BSX | In distribution | |
| PG3960BSS | In distribution | |
| PG1250BSS | In distribution | |
| PG2980BSX | In distribution | |
| PG1860BSS | In distribution | |
| PG1580BSS | In distribution | |
| PG2460BSS | In distribution | |
| PG2970BSS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Zimmon | Cook Ireland Ltd | 213 |
| Single Use Biliary Drainage Stent V | Olympus Medical Systems Corp. | 181 |
| Mustang™ | Boston Scientific Corporation | 167 |
| Geenen | Cook Ireland Ltd | 158 |
| Cotton-Leung | Cook Ireland Ltd | 144 |
| Advanix™ Pancreatic Stent | Boston Scientific Corporation | 135 |
| Single Use Biliary Stent V | Olympus Medical Systems Corp. | 106 |
| Single-use Balloon Dilatation Catheter | LEO Medical Co., Ltd. | 102 |
| Biliary Plastic Stent Set | Micro-Tech (Nanjing) Co., Ltd. | 90 |
| Biliary Plastic Stent | Micro-Tech (Nanjing) Co., Ltd. | 90 |
| M-Drain | Mermaid Medical A/S | 86 |
| Advanix™ Biliary | Boston Scientific Corporation | 84 |
Showing 12 of 212. All products under Stents, Drains And Dilators For The Biliary Ducts
Recalls
10 of these are Class II. 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 |
|---|---|---|---|---|---|
| 2022-05-20 | Class II | Process design | Potential for stent dislodgement and associated failures related to two specific sizes of the device. | 1,089 units | |
| 2021-10-01 | Class II | Process control | There is a potential for distal tip dislodgement or separation. | 4 units | |
| 2021-10-01 | Class II | Process control | There is a potential for distal tip dislodgement or separation. | 4 units | |
| 2021-10-01 | Class II | Process control | There is a potential for distal tip dislodgement or separation. | 26 units | |
| 2021-10-01 | Class II | Process control | There is a potential for distal tip dislodgement or separation. | 4 units | |
| 2021-10-01 | Class II | Process control | There is a potential for distal tip dislodgement or separation. | 3 units | |
| 2021-10-01 | Class II | Process control | There is a potential for distal tip dislodgement or separation. | 9 units | |
| 2017-11-15 | Class II | Nonconforming Material/Component | Potential for cracked luer hubs | 511 | 2019-11-04 |
| 2013-04-23 | Class II | Package design/selection | Holes and/or tears can be introduced in the FLEXSTENT inner pouch under some conditions, and to a lesser degree, in the outer pouch. | 23 units | 2014-06-27 |
| 2013-04-23 | Class II | Package design/selection | Holes and/or tears can be introduced in the FLEXSTENT inner pouch under some conditions, and to a lesser degree, in the outer pouch. | 1357 units | 2014-06-27 |
| 2012-04-09 | Not classified | Packaging process control | Cordis Corporation is recalling 32 lots of Cordis S.M.A.R.T. Nitinol Stent Transhepatic Biliary System and S.M.A.R.T. Control Nitinol Stent Transhepatic Biliary System. There is a potential for a sterility breach due to holes or tears in | 278 units | 2013-12-24 |
| 2012-04-09 | Not classified | Packaging process control | Cordis Corporation is recalling 32 lots of Cordis S.M.A.R.T. Nitinol Stent Transhepatic Biliary System and S.M.A.R.T. Control Nitinol Stent Transhepatic Biliary System. There is a potential for a sterility breach due to holes or tears in | 984 uits | 2013-12-24 |
| 2012-01-31 | Not classified | Packaging | Cordis Corporation initiated a recall of S.M.A.R.T. CONTROL Transhepatic Biliary Stent due to a potential sterility breach in the pouches. | 18,000 units | 2014-08-08 |
| 2004-01-13 | Not classified | Other | Air may be introduced into this Stent system when used with certain size acessory devices. | 7815 | 2010-08-30 |
| 2003-02-03 | Not classified | Other | The SMART Control Stent Delivery System may not fully deploy or be difficult to deploy under certain circumstances. | 32000 | 2010-09-08 |
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.