Single-use Balloon Dilatation Catheter
K-Number: K241888 · 2024-12-20
Device Summary
Frequently Asked Questions
What is the Single-use Balloon Dilatation Catheter?
Single-use Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2024-12-20. The listed applicant is Leo Medical Co., Ltd.. The 510(k) number is K241888.
When did Single-use Balloon Dilatation Catheter receive FDA 510(k) clearance?
Single-use Balloon Dilatation Catheter received FDA 510(k) clearance on 2024-12-20, under 510(k) number K241888.
Who is the listed applicant for Single-use Balloon Dilatation Catheter?
The FDA 510(k) record lists Leo Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Single-use Balloon Dilatation Catheter?
The FDA product code for Single-use Balloon Dilatation Catheter is FGE.
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 Leo Medical 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: FGE)
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.