FDA 510(k)

CerusEndo Microcatheter (027)

K-Number: K213314 · 2022-03-15

Decision Date2022-03-15

Product CodeQJP

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CerusEndo Microcatheter (027) is a medical device manufactured by Cerus Endovascular, Inc.. It received FDA 510(k) clearance on 2022-03-15 under approval number K213314. 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 CerusEndo Microcatheter (027)?

CerusEndo Microcatheter (027) is a medical device that received FDA 510(k) clearance on 2022-03-15. It is manufactured by Cerus Endovascular, Inc.. The 510(k) number is K213314.

When was CerusEndo Microcatheter (027) approved by the FDA?

CerusEndo Microcatheter (027) received FDA 510(k) clearance on 2022-03-15, under approval number K213314.

What company makes CerusEndo Microcatheter (027)?

CerusEndo Microcatheter (027) is manufactured by Cerus Endovascular, Inc..

What is the FDA product code for CerusEndo Microcatheter (027)?

The FDA product code for CerusEndo Microcatheter (027) is QJP.

Other Devices by Cerus Endovascular, Inc.

K182487CerusEndo Microcatheter

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.