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)

Q Distal Access Catheter

K-Number: K222948 · 2023-09-19

ApplicantMivi Neuroscience, Inc.
Decision Date2023-09-19
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Q Distal Access Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Mivi Neuroscience, Inc.. It received FDA 510(k) clearance on 2023-09-19 under 510(k) number K222948. 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 Q Distal Access Catheter?

Q Distal Access Catheter is a medical device that received FDA 510(k) clearance on 2023-09-19. The listed applicant is Mivi Neuroscience, Inc.. The 510(k) number is K222948.

When did Q Distal Access Catheter receive FDA 510(k) clearance?

Q Distal Access Catheter received FDA 510(k) clearance on 2023-09-19, under 510(k) number K222948.

Who is the listed applicant for Q Distal Access Catheter?

The FDA 510(k) record lists Mivi Neuroscience, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Q Distal Access Catheter?

The FDA product code for Q Distal Access Catheter is QJP.

Other records listing Mivi Neuroscience, 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.

K212402MIVI Q Distal Access CatheterK163233MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter

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.

↑