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FDA 510(k)

Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter

K-Number: K241388 · 2025-01-02

ApplicantMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
Decision Date2025-01-02
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter is a medical device manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. It received FDA 510(k) clearance on 2025-01-02 under approval number K241388. 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 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter?

Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter is a medical device that received FDA 510(k) clearance on 2025-01-02. It is manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K241388.

When was Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter approved by the FDA?

Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter received FDA 510(k) clearance on 2025-01-02, under approval number K241388.

What company makes Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter?

Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter is manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular.

What is the FDA product code for Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter?

The FDA product code for Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter is QJP.

Related Clinical Trials

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Other Devices by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

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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

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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