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FDA 510(k)

Superpipe Angiographic Catheter

K-Number: K193647 · 2020-07-29

ApplicantSuzhou Hengrui Disheng Medical Co., Ltd.
Decision Date2020-07-29
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Superpipe Angiographic Catheter is a medical device manufactured by Suzhou Hengrui Disheng Medical Co., Ltd.. It received FDA 510(k) clearance on 2020-07-29 under approval number K193647. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Superpipe Angiographic Catheter?

Superpipe Angiographic Catheter is a medical device that received FDA 510(k) clearance on 2020-07-29. It is manufactured by Suzhou Hengrui Disheng Medical Co., Ltd.. The 510(k) number is K193647.

When was Superpipe Angiographic Catheter approved by the FDA?

Superpipe Angiographic Catheter received FDA 510(k) clearance on 2020-07-29, under approval number K193647.

What company makes Superpipe Angiographic Catheter?

Superpipe Angiographic Catheter is manufactured by Suzhou Hengrui Disheng Medical Co., Ltd..

What is the FDA product code for Superpipe Angiographic Catheter?

The FDA product code for Superpipe Angiographic Catheter is DQO.

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

K171665Microcatheter and guide-wire system K193653Hydrophilic Coating Guide Wire

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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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