Bard Balloon Dilatation System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K863437 FDA 510(k)
- FDA Product Code
- FGE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5010 FDA 510(k)
- Regulation Number
- 876.5010 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Bard Balloon Dilatation System is a Stent, Drain, and Dilator for the Biliary Ducts, classified under FDA product code FGE. This device is designed to mechanically widen obstructed or narrowed biliary ducts through controlled dilation, facilitating bile flow and relieving obstruction in clinical settings such as biliary strictures or post-surgical stenosis. It operates via the insertion of a balloon catheter, which is inflated to expand the ductal lumen under radiographic guidance.
The system is intended for use in procedural settings such as endoscopy or fluoroscopy suites, where real-time imaging ensures precise placement. Supplied as a single-use device, it requires sterile handling and is regulated under FDA 510(k) clearance (K863437) as a Class II medical device. No MRI safety information is specified, and the system is not reusable. Storage conditions are not detailed in the regulatory data, but standard sterile medical device storage practices apply.
Frequently asked questions
What is the Bard Balloon Dilatation System used for?
The Bard Balloon Dilatation System is designed to mechanically widen narrowed or obstructed biliary ducts, improving bile flow in clinical conditions such as biliary strictures or post-surgical stenosis. It uses a balloon catheter inflated under radiographic guidance to expand the ductal lumen precisely, ensuring effective relief of obstructions in procedures like endoscopy or fluoroscopy.
How is the Bard Balloon Dilatation System supplied and handled?
The system is supplied as a single-use device, meaning each unit is intended for one-time use only. This design ensures sterility and reduces the risk of cross-contamination. Sterile handling is critical, as the device is not meant to be reused, and proper storage under standard sterile medical device practices is recommended.
Is the Bard Balloon Dilatation System reusable?
No, the Bard Balloon Dilatation System is explicitly designed for single-use only. This is a standard practice for devices intended to maintain sterility and safety, particularly in procedures involving direct contact with internal body structures like the biliary ducts.
What regulatory clearance does the Bard Balloon Dilatation System have?
The Bard Balloon Dilatation System holds FDA 510(k) clearance under the classification of Stents, Drains, and Dilators for the Biliary Ducts (product code FGE). This clearance confirms that the device meets regulatory standards for safety and effectiveness as a Class II medical device.
Are there any specific storage instructions for the Bard Balloon Dilatation System?
While the regulatory data does not specify exact storage conditions, the system should be stored according to standard sterile medical device practices. This typically includes keeping the device in a clean, dry environment, protected from contamination, and adhering to manufacturer guidelines to maintain its integrity until use.
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: BARD BALLOON DILATATION SYSTEM (K863437) — FDA 510 (k) | Innolitics, K863437 FDA 510 (k) - BARD BALLOON DILATATION SYSTEM, True™ Dilatation Balloon Valvuloplasty Catheters - BD, C.R. Bard, Inc. FDA 510 (k) Products - Latest 2026
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K863437 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K863437 24 fields · synced Oct 1, 2026