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FDA 510(k)

RIST Cath Radial Access Long Sheath

K-Number: K191551 · 2019-12-23

ApplicantRist Neurovascular, Inc.
Decision Date2019-12-23
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RIST Cath Radial Access Long Sheath 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 2019-12-23 under 510(k) number K191551. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIST Cath Radial Access Long Sheath?

RIST Cath Radial Access Long Sheath is a medical device that received FDA 510(k) clearance on 2019-12-23. The listed applicant is Rist Neurovascular, Inc.. The 510(k) number is K191551.

When did RIST Cath Radial Access Long Sheath receive FDA 510(k) clearance?

RIST Cath Radial Access Long Sheath received FDA 510(k) clearance on 2019-12-23, under 510(k) number K191551.

Who is the listed applicant for RIST Cath Radial Access Long Sheath?

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 Cath Radial Access Long Sheath?

The FDA product code for RIST Cath Radial Access Long Sheath is DQY.

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.

NCT07257367Pressure Sensing Sheath Blood Pressure Monitoring Compared to Traditional Methods in Interventional ProceduresRECRUITING

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.

K201682RIST Radial Access CatheterK200417RIST Radial Access Catheter

Related Devices (Code: DQY)

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.

K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbottK261631Amplatzer TorqVue Exchange SystemAbbott Medical

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.

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