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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 the device name listed in this FDA 510(k) record. The listed applicant is Q'Apel. It received FDA 510(k) clearance on 2018-09-13 under 510(k) 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. The listed applicant is Q'Apel. The 510(k) number is K181000.

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

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

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

The FDA 510(k) record lists Q'Apel 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 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.

K190749087 Balloon Guide Catheter System

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

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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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