Disposable Multistage Dilation Balloon Catheter
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Device Name
- Dilation Balloon Catheter EUDAMED
- Model / Reference
- EC01002 EUDAMEDEC01008 EUDAMEDEC01001 EUDAMEDEC01000 EUDAMEDEC01004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06902284524330 EUDAMED06902284524392 EUDAMED06902284524323 EUDAMED06902284524316 EUDAMED06902284524354 EUDAMED
- Basic UDI-DI
- 6902284EC457129U EUDAMED
- 510(k) Number
- K151671 FDA 510(k)
- FDA Product Code
- FGE FDA 510(k)
- EMDN Code
- G0301010402 BILIARY BALLOON CATHETERS, HIGH PRESSURE EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5010 FDA 510(k)
- Regulation Number
- 876.5010 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Disposable Multistage Dilation Balloon Catheter is a Stent, Drain, and Dilator for the Biliary Ducts (per FDA nomenclature, classification II). It is a single-use, disposable device designed for controlled dilation of biliary or gastrointestinal strictures. The catheter features a balloon that expands sequentially to three predefined diameters, enabling progressive and even pressure distribution along its working length. This design facilitates stepwise dilation at defined pressure levels, reducing the risk of over-expansion or trauma during the procedure.
This device is intended for use in endoscopic procedures within the biliary or gastrointestinal tract. Supplied sterile and intended for single-use only, it requires no reprocessing. The catheter is compatible with MRI environments, though specific MRI safety instructions must be followed as per the included instructions for use. Available in various sizes, it is stored in protective packaging to maintain sterility until use. The device holds FDA 510(k) clearance and MDR compliance, ensuring regulatory adherence for its intended applications.
Frequently asked questions
What is the primary purpose of the Disposable Multistage Dilation Balloon Catheter in clinical procedures?
The Disposable Multistage Dilation Balloon Catheter is specifically designed for controlled dilation of biliary or gastrointestinal strictures during endoscopic procedures. Its multistage balloon expands sequentially to predefined diameters, allowing for progressive and even pressure distribution along its length. This design helps reduce the risk of over-expansion or trauma, making it suitable for stepwise dilation in these anatomical areas.
How is the device supplied, and what are the key considerations for handling it?
The device is supplied sterile and intended for single-use only, meaning it requires no reprocessing after use. It comes in protective packaging to maintain sterility until use, so it’s important to keep the packaging intact until immediately before the procedure. Since it’s disposable, proper disposal protocols should follow local regulations after use.
Are there different sizes or models available for this catheter, and how might that affect my selection?
While the exact sizes or models aren’t detailed in the provided data, the device is described as available in *various sizes*. This suggests flexibility to accommodate different patient anatomies or procedural needs. When selecting a size, consider the specific diameter of the biliary or gastrointestinal stricture you’re targeting, as well as compatibility with your endoscopic equipment to ensure optimal performance.
Can this catheter be used safely in an MRI environment, and what precautions should be taken?
Yes, the Disposable Multistage Dilation Balloon Catheter is compatible with MRI environments, but specific safety instructions must be followed as outlined in the included instructions for use. This means verifying the device’s labeling for MRI-safe materials and adhering to any guidelines provided by the manufacturer to avoid risks during imaging. Always consult the IFU for detailed MRI safety protocols.
What regulatory pathways has this device undergone, and how does that impact its use in clinical practice?
The device holds FDA 510(k) clearance and MDR compliance, confirming it meets regulatory standards for safety and effectiveness in its intended applications. This means it has been reviewed and authorized for use in the U.S. and EU markets (where applicable), ensuring adherence to strict manufacturing, performance, and clinical guidelines. Clinicians can rely on its regulatory backing when incorporating it into biliary or gastrointestinal dilation procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Multi-Stage Dilation Balloons - MICRO-TECH EUROPE, Multistage Dilation Balloon - MICRO-TECH, Multi-Stage Dilation Balloon - Micro-Tech Endoscopy, Disposable Multistage Dilation Balloon Catheter
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K151671 | Class II | Active |
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Manufacturer
- Manufacturer
- Micro-Tech (Nanjing) Co., Ltd.
Sources (6)
- FDA 510(k) K151671 24 fields · synced Sep 20, 2026
- EUDAMED 517095e5-2dc6-4f4c-bc78-ce86990b55dd 61 fields · synced Jul 15, 2026
- EUDAMED 0bf62671-7071-404d-b050-fba03e0fba08 61 fields · synced Jul 20, 2026
- EUDAMED fe38fdd8-24e5-4320-a9ce-6b6374ffd94b 61 fields · synced Jul 21, 2026
- EUDAMED d23970bf-aab8-4716-ad6f-d7c2f3f7424f 61 fields · synced Jul 25, 2026
- EUDAMED 5e6f02a0-33ae-476c-bb21-c03aee09945b 61 fields · synced Jul 26, 2026