Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ADROIT GUIDING CATHETER

K-Number: K131225 · 2013-05-29

ApplicantCordis Corp., A Johnson & Johnson Co.
Decision Date2013-05-29
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ADROIT GUIDING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp., A Johnson & Johnson Co.. It received FDA 510(k) clearance on 2013-05-29 under 510(k) number K131225. 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 ADROIT GUIDING CATHETER?

ADROIT GUIDING CATHETER is a medical device that received FDA 510(k) clearance on 2013-05-29. The listed applicant is Cordis Corp., A Johnson & Johnson Co.. The 510(k) number is K131225.

When did ADROIT GUIDING CATHETER receive FDA 510(k) clearance?

ADROIT GUIDING CATHETER received FDA 510(k) clearance on 2013-05-29, under 510(k) number K131225.

Who is the listed applicant for ADROIT GUIDING CATHETER?

The FDA 510(k) record lists Cordis Corp., A Johnson & Johnson Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADROIT GUIDING CATHETER?

The FDA product code for ADROIT GUIDING 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 Cordis Corp., A Johnson & Johnson Co. 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.

K091077OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETERK083814OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120K062531ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑