Disposable Balloon Catheter
Olympus B5-2C is a disposable balloon catheter passed through a compatible bronchoscope's instrument channel. It delivers medical fluid or saline into the bronchi and can inflate a balloon…
Olympus B5-2C is a disposable balloon catheter passed through a compatible bronchoscope’s instrument channel. It delivers medical fluid or saline into the bronchi and can inflate a balloon for local tamponade to control bleeding.
The catheter combines a natural rubber latex balloon with a polyethylene tube, branching connection, irrigation port, air-feed cap and stopcock. The balloon is inflated at the target area and deflated before removal.
Bronchoscopic Configuration
The inflatable balloon reaches a maximum diameter of 11 mm. Fluid injection supports bronchial procedures including bronchoalveolar lavage, while the balloon provides the mechanical tamponade function. The catheter is supplied sterile and is intended for the specified bronchoscopic applications.
Who Else Makes It
Concentrated in Guangdong (7), Zhejiang (5), Jiangsu (4). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Guangdong MacroLux Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
| Ningbo Wise Optomech Technology Corporation | Ningbo | Zhejiang | Contract manufacturer | 4 |
| Hangzhou Broncus Medical Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 1 |
| Tianjin Puli Ark Medical Technology Co., Ltd. | Dongli District | Tianjin | Contract manufacturer | 1 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Zhejiang Huanyi Sterilization Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 25 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Suzhou Virgil Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Anrei Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 12 |
Showing 12 of 21. All 21 manufacturers in China registered for Bronchoscope (Flexible Or Rigid)
Record
| Listed by | Olympus Medical Systems Corp., Japan |
|---|---|
| FDA product code | EOQ |
| Device type | Bronchoscope (Flexible Or Rigid) |
| Device class | Class 2 |
| Regulation | 21 CFR 874.4680 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K250118 |
| Record published | 2016-09-21 |
| Record revised | 2025-11-24 (version 7) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B5-2C | In distribution | |
| B5-2C | In distribution | |
| B7-2C | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bronchoscope (Flexible Or Rigid) | Karl Storz GmbH & Co. KG | 248 |
| Pentax | Hoya Corporation | 39 |
| Biopsy Forceps | Olympus Medical Systems Corp. | 31 |
| Single-Use flexible Video Bronchoscope | Hunan Vathin Medical Instrument Co., Ltd. | 27 |
| Pilling | Teleflex Medical LLC | 24 |
| Silicone cap | Efer Endoscopy | 22 |
| Bronchoscope (Flexible Or Rigid) | Intuitive Surgical, Inc. | 20 |
| Endoso | Hunan Endoso Life Technology Co., Ltd. | 20 |
| Exalt ™ | Boston Scientific Corporation | 17 |
| Grasping Forceps | Olympus Medical Systems Corp. | 16 |
| LungVision Tool | Body Vision Medical Ltd | 16 |
| Fujifilm | Fujifilm Corporation | 15 |
Showing 12 of 255. All products under Bronchoscope (Flexible Or Rigid)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252341 | 2026-04-23 |
| K250862 | 2025-06-23 |
| K250118 | 2025-06-04 |
| K250957 | 2025-05-30 |
| K222861 | 2023-06-15 |
| K221631 | 2022-09-26 |
| K212667 | 2021-09-22 |
| K201300 | 2021-01-26 |
| K201758 | 2021-01-21 |
| K200342 | 2020-12-17 |
| K200397 | 2020-04-24 |
| K192164 | 2020-03-06 |
| K183419 | 2019-09-05 |
| K172726 | 2018-04-30 |
| K121959 | 2013-01-10 |
| K082720 | 2008-11-05 |
| K061313 | 2006-08-31 |
| K060243 | 2006-06-23 |
| K050220 | 2005-02-10 |
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.