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FDA 510(k)

RIST Radial Access Catheter

K-Number: K201682 · 2020-09-28

ApplicantRist Neurovascular, Inc.
Decision Date2020-09-28
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RIST Radial Access Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Rist Neurovascular, Inc.. It received FDA 510(k) clearance on 2020-09-28 under 510(k) number K201682. 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 2020-09-28. The listed applicant is Rist Neurovascular, Inc.. The 510(k) number is K201682.

When did RIST Radial Access Catheter receive FDA 510(k) clearance?

RIST Radial Access Catheter received FDA 510(k) clearance on 2020-09-28, under 510(k) number K201682.

Who is the listed applicant for RIST Radial Access Catheter?

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

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

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.

NCT07762560Routine Microaxial Heart Pump Support and Protocolized Pulmonary Artery Catheter Monitoring Versus Standard Care in Heart Attack-Related Cardiogenic ShockNOT_YET_RECRUITING

Other records listing Rist Neurovascular, 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.

K200417RIST Radial Access CatheterK191551RIST Cath Radial Access Long Sheath

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.

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