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FDA 510(k)

Balloon Inflation System

K-Number: K232842 · 2024-02-29

ApplicantNingbo Hicren Biotechnology Co., Ltd.
Decision Date2024-02-29
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Balloon Inflation System is a medical device manufactured by Ningbo Hicren Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2024-02-29 under approval number K232842. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Balloon Inflation System?

Balloon Inflation System is a medical device that received FDA 510(k) clearance on 2024-02-29. It is manufactured by Ningbo Hicren Biotechnology Co., Ltd.. The 510(k) number is K232842.

When was Balloon Inflation System approved by the FDA?

Balloon Inflation System received FDA 510(k) clearance on 2024-02-29, under approval number K232842.

What company makes Balloon Inflation System?

Balloon Inflation System is manufactured by Ningbo Hicren Biotechnology Co., Ltd..

What is the FDA product code for Balloon Inflation System?

The FDA product code for Balloon Inflation System is NDN.

Related Clinical Trials

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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.

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