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FDA 510(k)

SCHNEIDER GEX(TM) .014/.018 GUIDEWIRE EXCHANGE CATHETER

K-Number: K950047 · 1995-04-05

ApplicantIsomedix Operations, Inc.
Decision Date1995-04-05
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SCHNEIDER GEX(TM) .014/.018 GUIDEWIRE EXCHANGE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Isomedix Operations, Inc.. It received FDA 510(k) clearance on 1995-04-05 under 510(k) number K950047. 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 SCHNEIDER GEX(TM) .014/.018 GUIDEWIRE EXCHANGE CATHETER?

SCHNEIDER GEX(TM) .014/.018 GUIDEWIRE EXCHANGE CATHETER is a medical device that received FDA 510(k) clearance on 1995-04-05. The listed applicant is Isomedix Operations, Inc.. The 510(k) number is K950047.

When did SCHNEIDER GEX(TM) .014/.018 GUIDEWIRE EXCHANGE CATHETER receive FDA 510(k) clearance?

SCHNEIDER GEX(TM) .014/.018 GUIDEWIRE EXCHANGE CATHETER received FDA 510(k) clearance on 1995-04-05, under 510(k) number K950047.

Who is the listed applicant for SCHNEIDER GEX(TM) .014/.018 GUIDEWIRE EXCHANGE CATHETER?

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

What is the FDA product code for SCHNEIDER GEX(TM) .014/.018 GUIDEWIRE EXCHANGE CATHETER?

The FDA product code for SCHNEIDER GEX(TM) .014/.018 GUIDEWIRE EXCHANGE CATHETER 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Isomedix Operations, 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.

K970352SMARTVAC SMOKE EVACUATION SYSTEM

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.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.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 CatheterAbbott

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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