Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Q'Apel Medical, Inc.. It received FDA 510(k) clearance on 2021-08-05 under 510(k) 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. The listed applicant is Q'Apel Medical, Inc.. The 510(k) number is K211893.

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

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

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

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

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

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

Other records listing Q'Apel Medical, Inc. 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 FamilyK192525087 Balloon Guide Catheter SystemK191664SelectFlex 072 Neurovascular Access System

View all 7 devices →

Related Devices (Code: QJP)

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.

K260199SLIM MicrocatheterBalt USA, LLCK253901Millipede88 Access CatheterPerfuze, Ltd.K261889Trevo Trak 21 MicrocatheterStryker NeurovascularK261808ISAAC Neurovascular Navigation CatheterMicrovention Inc. d/b/a Terumo NeuroK261549BOBBY Balloon Guide CatheterMicroVention, Inc., d/b/a Terumo NeuroK253359Zenith Distal Access Long SheathSuzhou Zenith Vascular SciTech Limited

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.

↑