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FDA 510(k)

Micro Catheter

K-Number: K202926 · 2022-02-10

ApplicantShanghai Heartcare Medical Technology Co., Ltd.
Decision Date2022-02-10
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Micro Catheter is a medical device manufactured by Shanghai Heartcare Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-02-10 under approval number K202926. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Micro Catheter?

Micro Catheter is a medical device that received FDA 510(k) clearance on 2022-02-10. It is manufactured by Shanghai Heartcare Medical Technology Co., Ltd.. The 510(k) number is K202926.

When was Micro Catheter approved by the FDA?

Micro Catheter received FDA 510(k) clearance on 2022-02-10, under approval number K202926.

What company makes Micro Catheter?

Micro Catheter is manufactured by Shanghai Heartcare Medical Technology Co., Ltd..

What is the FDA product code for Micro Catheter?

The FDA product code for Micro Catheter is QJP.

Related Clinical Trials

NCT05996159 Pulmonary Vein Isolation Strategy of Very High Power Short Duration in Patients With Paroxysmal Atrial Fibrillation RECRUITING NCT07370246 CAS for Stenosis With High-risk Features for CEA RECRUITING

Other Devices by Shanghai Heartcare Medical Technology Co., Ltd.

K202916Balloon Guiding Catheter K233205Distal Access Catheter

Related Devices (Code: QJP)

K203043Route 92 Medical 070 Access SystemRoute 92 Medical, Inc. K201682RIST Radial Access CatheterRist Neurovascular, Inc. K201518Route 92 Medical 088 Access SystemRoute 92 Medical K201076Anchor Dual Lumen Guidewire CatheterAqure Medical, Inc. K200910BOSS Balloon Guide CatheterMarblehead Medical K200417RIST Radial Access CatheterRist Neurovascular, Inc.

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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