MultiStage Balloon Dilatation Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K222663 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)
A MultiStage Balloon Dilatation Catheter is a device used for endoscopic dilation of strictures in the gastrointestinal and respiratory tracts. It is classified as a stent, drain, or dilator for the biliary ducts under FDA device classification.
The device is supplied sterile and intended for single-use. It has received FDA 510(k) clearance (K222663) as substantially equivalent to a predicate device, with review by the Gastroenterology and Urology advisory committee. It is manufactured by Dongguan TT Medical, Inc. and is regulated under regulation number 876.5010.
Frequently asked questions
What is the MultiStage Balloon Dilatation Catheter used for?
It is used for endoscopic dilation of strictures in the gastrointestinal and respiratory tracts, functioning as a stent, drain, or dilator specifically for biliary ducts under FDA classification.
How is the MultiStage Balloon Dilatation Catheter supplied and intended for use?
The device is supplied sterile and intended for single-use only, as stated in its regulatory submission and manufacturing specifications.
What regulatory pathway was used for the MultiStage Balloon Dilatation Catheter?
It received FDA 510(k) clearance (K222663) as substantially equivalent to a predicate device, with review by the Gastroenterology and Urology advisory committee under regulation number 876.5010.
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: MultiStage® Balloon Dilatation Catheter (Pulmonary) - TT Medical, Inc, MultiStage® Balloon Dilatation Catheter (Pulmonary) - TT Medical, Inc, K222663 FDA 510 (k) - MultiStage Balloon Dilatation Catheter, K222663 · MultiStage Balloon… · DeviceClearance
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222663 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dongguan Tt Medical, Inc.
Sources (1)
- FDA 510(k) K222663 24 fields · synced Sep 22, 2026