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FDA 510(k)

SelectFlex 072 Neurovascular Access System

K-Number: K191664 · 2019-08-30

ApplicantQ'Apel Medical
Decision Date2019-08-30
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SelectFlex 072 Neurovascular Access System is a medical device manufactured by Q'Apel Medical. It received FDA 510(k) clearance on 2019-08-30 under approval number K191664. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SelectFlex 072 Neurovascular Access System?

SelectFlex 072 Neurovascular Access System is a medical device that received FDA 510(k) clearance on 2019-08-30. It is manufactured by Q'Apel Medical. The 510(k) number is K191664.

When was SelectFlex 072 Neurovascular Access System approved by the FDA?

SelectFlex 072 Neurovascular Access System received FDA 510(k) clearance on 2019-08-30, under approval number K191664.

What company makes SelectFlex 072 Neurovascular Access System?

SelectFlex 072 Neurovascular Access System is manufactured by Q'Apel Medical.

What is the FDA product code for SelectFlex 072 Neurovascular Access System?

The FDA product code for SelectFlex 072 Neurovascular Access System is DQY.

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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) PMID: 37288633 [Roadmap of Medical Device for Implanted Brain-computer Interface]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2023) PMID: 36476364 ScanMedicine: An online search system for medical innovation. Contemporary clinical trials (2023) PMID: 29988408 Regulation of Neurological Devices and Neurointerventional Endovascular Approaches for Acute Ischemic Stroke. Frontiers in neurology (2018)

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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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