Balloon Dilatation Catheter
K-Number: K213578 · 2022-04-06
Device Summary
Frequently Asked Questions
What is the Balloon Dilatation Catheter?
Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2022-04-06. The listed applicant is Hangzhou AGS MedTech Co., Ltd.. The 510(k) number is K213578.
When did Balloon Dilatation Catheter receive FDA 510(k) clearance?
Balloon Dilatation Catheter received FDA 510(k) clearance on 2022-04-06, under 510(k) number K213578.
Who is the listed applicant for Balloon Dilatation Catheter?
The FDA 510(k) record lists Hangzhou AGS MedTech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Balloon Dilatation Catheter?
The FDA product code for Balloon Dilatation Catheter is FDF.
Related Clinical Trials
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Other records listing Hangzhou AGS MedTech Co., Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: FDF)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.