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FDA 510(k)

Micro Catheter and Guidewire System

K-Number: K212719 · 2022-04-11

ApplicantSuzhou Hengrui Hongyuan Medical Co., Ltd.
Decision Date2022-04-11
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Micro Catheter and Guidewire System is a medical device manufactured by Suzhou Hengrui Hongyuan Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-04-11 under approval number K212719. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Micro Catheter and Guidewire System?

Micro Catheter and Guidewire System is a medical device that received FDA 510(k) clearance on 2022-04-11. It is manufactured by Suzhou Hengrui Hongyuan Medical Co., Ltd.. The 510(k) number is K212719.

When was Micro Catheter and Guidewire System approved by the FDA?

Micro Catheter and Guidewire System received FDA 510(k) clearance on 2022-04-11, under approval number K212719.

What company makes Micro Catheter and Guidewire System?

Micro Catheter and Guidewire System is manufactured by Suzhou Hengrui Hongyuan Medical Co., Ltd..

What is the FDA product code for Micro Catheter and Guidewire System?

The FDA product code for Micro Catheter and Guidewire System is KRA.

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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.

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