Single Use 3-Lumen Extraction Balloon V
13 catalogue numbers from B-V243Q-B, listed by Olympus Medical Systems Corp., Japan, under Stents, Drains And Dilators For The Biliary Ducts. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
13catalogue numbers in this listing
3510(k) clearances naming this product 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 | Olympus Medical Systems Corp., Japan |
|---|---|
| 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, Manufacturer, Exporter |
| 510(k) | K091495 |
| Record published | 2016-09-21 |
| Record revised | 2025-11-24 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 15 |
| Distribution end date | 2024-07-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B-V243Q-B | In distribution | |
| B-V233P-A | In distribution | |
| B-V243Q-A | In distribution | |
| B-V433P-B | In distribution | |
| B-V433P-A | In distribution | |
| B-V443Q-A | In distribution | |
| B-V433P-A | In distribution | |
| B-V443Q-B | In distribution | |
| B-V231P-A | Withdrawn | |
| B-V433P-B | Withdrawn | |
| B-V231P-B | Withdrawn | |
| B-V443Q-B | Withdrawn | |
| B-V243Q-A | Withdrawn |
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 |
|---|---|
| K250409 | 2025-10-21 |
| K143303 | 2015-02-27 |
| K103478 | 2011-02-24 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Aomori Olympus Co., Ltd. Kuroishi Site | 510(k) number | 2021-01-04 | Class II | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. | 7,400,000 (global); 260,395 (US) | 2024-03-11 |
| Aomori Olympus Co., Ltd. Kuroishi Site | 510(k) number | 2021-01-04 | Class II | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. | 7,400,000 (global); 260,395 (US) | 2024-03-11 |
| Aomori Olympus Co., Ltd. Kuroishi Site | 510(k) number | 2021-01-04 | Class II | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. | 7,400,000 (global); 260,395 (US) | 2024-03-11 |
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.