Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-52
Summary
Hangzhou AGS MedTech Co., Ltd. received 510(k) clearance for Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019, a FGE device. Cleared on 2026-06-24.
Details
Source
510(k) Clearance
External ID
K253393
Action Date
2026-06-24
Status
Traditional
Category
device
Product Code
FGE
Product Description
Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019. Product code: FGE.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 389 device clearances issued this month. Hangzhou AGS MedTech Co., Ltd. has received 9 total clearances in our database.
Hangzhou AGS MedTech Co., Ltd. has 9 FDA actions in our database, including 9 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Hangzhou AGS MedTech Co., Ltd. have FDA actions?
Hangzhou AGS MedTech Co., Ltd. has 9 FDA actions in our database, including 0 recalls and 9 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K253393" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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