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FDA 510(k)

SelectFlex 072 Neurovascular Access System

K-Number: K181000 · 2018-09-13

ApplicantQ'Apel
Decision Date2018-09-13
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SelectFlex 072 Neurovascular Access System is a medical device manufactured by Q'Apel. It received FDA 510(k) clearance on 2018-09-13 under approval number K181000. 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 2018-09-13. It is manufactured by Q'Apel. The 510(k) number is K181000.

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

SelectFlex 072 Neurovascular Access System received FDA 510(k) clearance on 2018-09-13, under approval number K181000.

What company makes SelectFlex 072 Neurovascular Access System?

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

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)

Other Devices by Q'Apel

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Related Devices (Code: DQY)

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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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