Stents, Drains and Dilators for the Biliary Ducts
Laparoscopic Cholangiography Catheter 4F 80CM
6manufacturers in China registered for this device type
1catalogue number
7510(k) clearances naming this product code
40recalls 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 | Edwards Lifesciences Technology Sarl, 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 | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K905707 |
| Record published | 2016-09-03 |
| Record revised | 2020-11-19 (version 4) |
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, expiry date, manufacturing date |
| Storage | Special storage condition: STORE IN A COOL, DRY PLACE. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 420804F | CATHETER SIZE: 4F (1.33MM), CATHETER LENGTH: 80CM | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K061235 | 2006-06-05 |
| K060487 | 2006-03-23 |
| K053404 | 2005-12-21 |
| K052132 | 2005-08-24 |
| K050627 | 2005-03-22 |
| K042985 | 2004-12-23 |
| K024303 | 2003-07-03 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | Lot #FR6H0204 – 1 UNIT; RFR6H0206 – 13 UNITS | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | Lot # FR6H0173 – 1 UNIT | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | Lot # FR6G0118 – 3 UNITS, FR6G0119 – 2 UNITS, FR6H0137 – 5 U | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | 3 UNITS | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | Lot # FR6G0126 – 7 UNITS, FR6G0127 – 6 UNITS, FR6H0200 – 4 U | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | 1 UNIT | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | 2 UNITS | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | 1 UNIT | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | 10 UNITS | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | 4 UNITS | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | 6 UNITS | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | Lot # FR6G0124 – 5 UNITS, FR6G0125 – 2 UNITS, FR6H0181 – 2 U | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | 3 UNITS | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | Lot #FR6H0139 – 19 UNITS, FR6H0199 – 6 UNITS | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | 2 UNITS | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | 8 UNITS | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | 1 UNIT | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | 16 UNITS | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | 1 UNIT | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | 14 UNITS | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | 9 UNITS | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | 9 UNITS | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | 4 UNITS | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | 9 UNITS | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | 8 UNITS | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | 21 UNITS | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | 8 UNITS | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | 9 UNITS | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | 7 UNITS | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | 2 UNITS | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | 22 UNITS | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | 3 UNITS | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | 4 UNITS | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | 2 UNITS | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | 4 UNITS | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | 10 UNITS | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | 9 UNITS | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | Lot #FR6G0122 – 3 UNITS, FR6G0123 – 2 UNITS, FR6H0193 – 4 UN | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | 3 UNITS | 2012-01-11 |
| 2007-12-05 | Not classified | Packaging process control | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | 1 UNIT | 2012-01-11 |
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.