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FDA 510(k)

SelectFlex Neurovascular Access System Family

K-Number: K211893 · 2021-08-05

ApplicantQ'Apel Medical, Inc.
Decision Date2021-08-05
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SelectFlex Neurovascular Access System Family is a medical device manufactured by Q'Apel Medical, Inc.. It received FDA 510(k) clearance on 2021-08-05 under approval number K211893. 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 SelectFlex Neurovascular Access System Family?

SelectFlex Neurovascular Access System Family is a medical device that received FDA 510(k) clearance on 2021-08-05. It is manufactured by Q'Apel Medical, Inc.. The 510(k) number is K211893.

When was SelectFlex Neurovascular Access System Family approved by the FDA?

SelectFlex Neurovascular Access System Family received FDA 510(k) clearance on 2021-08-05, under approval number K211893.

What company makes SelectFlex Neurovascular Access System Family?

SelectFlex Neurovascular Access System Family is manufactured by Q'Apel Medical, Inc..

What is the FDA product code for SelectFlex Neurovascular Access System Family?

The FDA product code for SelectFlex Neurovascular Access System Family is QJP.

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Related PubMed Literature

PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025)

Other Devices by Q'Apel Medical, Inc.

K222786072 Aspiration System K230322SelectFlex Neurovascular Access System Family K240746Neurovascular Access System Family

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.

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