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FDA 510(k)

Reliant Multistage Dilatation Balloon Catheter

K-Number: K162226 · 2017-01-25

Decision Date2017-01-25
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Reliant Multistage Dilatation Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2017-01-25 under 510(k) number K162226. 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 Reliant Multistage Dilatation Balloon Catheter?

Reliant Multistage Dilatation Balloon Catheter is a medical device that received FDA 510(k) clearance on 2017-01-25. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K162226.

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

Reliant Multistage Dilatation Balloon Catheter received FDA 510(k) clearance on 2017-01-25, under 510(k) number K162226.

Who is the listed applicant for Reliant Multistage Dilatation Balloon Catheter?

The FDA 510(k) record lists Micro-Tech (Nanjing) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reliant Multistage Dilatation Balloon Catheter?

The FDA product code for Reliant Multistage Dilatation Balloon 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 Micro-Tech (Nanjing) 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.

View all 37 devices →

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.