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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 the device name listed in this FDA 510(k) record. The listed applicant is Q'Apel Medical. It received FDA 510(k) clearance on 2019-08-30 under 510(k) 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. The listed applicant is Q'Apel Medical. The 510(k) number is K191664.

When did SelectFlex 072 Neurovascular Access System receive FDA 510(k) clearance?

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

Who is the listed applicant for SelectFlex 072 Neurovascular Access System?

The FDA 510(k) record lists Q'Apel Medical as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Q'Apel Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254276Lynx Aspiration Catheter SystemK240746Neurovascular Access System FamilyK222786072 Aspiration SystemK230322SelectFlex Neurovascular Access System FamilyK211893SelectFlex Neurovascular Access System FamilyK192525087 Balloon Guide Catheter System

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Related Devices (Code: DQY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbottK261631Amplatzer TorqVue Exchange SystemAbbott Medical

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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