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FDA 510(k)

MultiStage Balloon Dilatation Catheter

K-Number: K222663 · 2023-03-09

Decision Date2023-03-09
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MultiStage Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan TT Medical, Inc.. It received FDA 510(k) clearance on 2023-03-09 under 510(k) number K222663. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MultiStage Balloon Dilatation Catheter?

MultiStage Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2023-03-09. The listed applicant is Dongguan TT Medical, Inc.. The 510(k) number is K222663.

When did MultiStage Balloon Dilatation Catheter receive FDA 510(k) clearance?

MultiStage Balloon Dilatation Catheter received FDA 510(k) clearance on 2023-03-09, under 510(k) number K222663.

Who is the listed applicant for MultiStage Balloon Dilatation Catheter?

The FDA 510(k) record lists Dongguan TT Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MultiStage Balloon Dilatation Catheter?

The FDA product code for MultiStage 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 Dongguan TT Medical, Inc. 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

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