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FDA 510(k)

RIST Radial Access Catheter

K-Number: K200417 · 2020-05-02

ApplicantRist Neurovascular, Inc.
Decision Date2020-05-02
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RIST Radial Access Catheter is a medical device manufactured by Rist Neurovascular, Inc.. It received FDA 510(k) clearance on 2020-05-02 under approval number K200417. 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 RIST Radial Access Catheter?

RIST Radial Access Catheter is a medical device that received FDA 510(k) clearance on 2020-05-02. It is manufactured by Rist Neurovascular, Inc.. The 510(k) number is K200417.

When was RIST Radial Access Catheter approved by the FDA?

RIST Radial Access Catheter received FDA 510(k) clearance on 2020-05-02, under approval number K200417.

What company makes RIST Radial Access Catheter?

RIST Radial Access Catheter is manufactured by Rist Neurovascular, Inc..

What is the FDA product code for RIST Radial Access Catheter?

The FDA product code for RIST Radial Access Catheter is QJP.

Related Clinical Trials

NCT07610681 Midline Catheter Study ACTIVE_NOT_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 NCT07510451 The Hypotension Prediction Index Versus Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic Surgery RECRUITING NCT02633124 Preventing Catheter-related Bacteremia When Administering Injectable Medications in Premature Infants. TERMINATED

Other Devices by Rist Neurovascular, Inc.

K191551RIST Cath Radial Access Long Sheath K201682RIST Radial 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 K200121Route 92 Medical 088 Access System, 110 cmRoute 92 Medical, Inc.

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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