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FDA 510(k)

Microcatheter and guide-wire system

K-Number: K171665 · 2018-01-11

ApplicantSuzhou Hengrui Disheng Medical Co., Ltd.
Decision Date2018-01-11
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Microcatheter and guide-wire system is a medical device manufactured by Suzhou Hengrui Disheng Medical Co., Ltd.. It received FDA 510(k) clearance on 2018-01-11 under approval number K171665. 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 Microcatheter and guide-wire system?

Microcatheter and guide-wire system is a medical device that received FDA 510(k) clearance on 2018-01-11. It is manufactured by Suzhou Hengrui Disheng Medical Co., Ltd.. The 510(k) number is K171665.

When was Microcatheter and guide-wire system approved by the FDA?

Microcatheter and guide-wire system received FDA 510(k) clearance on 2018-01-11, under approval number K171665.

What company makes Microcatheter and guide-wire system?

Microcatheter and guide-wire system is manufactured by Suzhou Hengrui Disheng Medical Co., Ltd..

What is the FDA product code for Microcatheter and guide-wire system?

The FDA product code for Microcatheter and guide-wire system is KRA.

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Other Devices by Suzhou Hengrui Disheng Medical Co., Ltd.

K193653Hydrophilic Coating Guide Wire K193647Superpipe Angiographic Catheter

Related Devices (Code: KRA)

K161962VAMP Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLC K160884CXI Support CatheterCook Incorporated K161921SwiftNINJA MicrocatheterMerit Medical Systems, Inc. K161402Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc. K161801CrossCath Support CatheterCook Incorporated K153501Bullfrog Micro-Infusion DeviceMercator Medsystems, 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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