FDA 510(k)

MIVI Q Distal Access Catheter

K-Number: K212402 · 2021-12-16

Decision Date2021-12-16

Product CodeQJP

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MIVI Q Distal Access Catheter is a medical device manufactured by Mivi Neuroscience, Inc.. It received FDA 510(k) clearance on 2021-12-16 under approval number K212402. 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 MIVI Q Distal Access Catheter?

MIVI Q Distal Access Catheter is a medical device that received FDA 510(k) clearance on 2021-12-16. It is manufactured by Mivi Neuroscience, Inc.. The 510(k) number is K212402.

When was MIVI Q Distal Access Catheter approved by the FDA?

MIVI Q Distal Access Catheter received FDA 510(k) clearance on 2021-12-16, under approval number K212402.

What company makes MIVI Q Distal Access Catheter?

MIVI Q Distal Access Catheter is manufactured by Mivi Neuroscience, Inc..

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

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

Related Clinical Trials

NCT07610681 Midline Catheter Study ACTIVE_NOT_RECRUITING NCT07410364 Safety and Efficacy of CAG and PCI Via Distal Transradial Access in Patients With Small Vessels RECRUITING NCT07585188 Neonatal Catheter Lock for Infection Prevention NOT_YET_RECRUITING NCT07512986 Simulation and Video Training for Phlebitis Recognition and Clinical Decision-Making in Nursing Students NOT_YET_RECRUITING NCT04498598 Structural Modification In Supraglottic Airway Device RECRUITING NCT07212855 Use of Glycine Powder and an Angled Implant Brush in Oral Hygiene Procedures in Patients Rehabilitated With Columbus Bridge Protocol COMPLETED

Other Devices by Mivi Neuroscience, Inc.

K163233MIVI 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 K222948Q Distal Access Catheter

Related Devices (Code: QJP)

K203043Route 92 Medical 070 Access SystemRoute 92 Medical, Inc. K201682RIST Radial Access CatheterRist Neurovascular, Inc. K201518Route 92 Medical 088 Access SystemRoute 92 Medical K201076Anchor Dual Lumen Guidewire CatheterAqure Medical, Inc. K200910BOSS Balloon Guide CatheterMarblehead Medical K200417RIST Radial Access CatheterRist Neurovascular, Inc.

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.