Micro Catheter and Guidewire System
K-Number: K212719 · 2022-04-11
Device Summary
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. The listed applicant is Suzhou Hengrui Hongyuan Medical Co., Ltd.. The 510(k) number is K212719.
When did Micro Catheter and Guidewire System receive FDA 510(k) clearance?
Micro Catheter and Guidewire System received FDA 510(k) clearance on 2022-04-11, under 510(k) number K212719.
Who is the listed applicant for Micro Catheter and Guidewire System?
The FDA 510(k) record lists Suzhou Hengrui Hongyuan Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Micro Catheter and Guidewire System?
The FDA product code for Micro Catheter and Guidewire System is KRA.
Other records listing Suzhou Hengrui Hongyuan 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: KRA)
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.