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)

REFLEX BALLON GUIDE CATHETER

K-Number: K112262 · 2011-11-02

ApplicantReverse Medical Corporation
Decision Date2011-11-02
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

REFLEX BALLON GUIDE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Reverse Medical Corporation. It received FDA 510(k) clearance on 2011-11-02 under 510(k) number K112262. 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 REFLEX BALLON GUIDE CATHETER?

REFLEX BALLON GUIDE CATHETER is a medical device that received FDA 510(k) clearance on 2011-11-02. The listed applicant is Reverse Medical Corporation. The 510(k) number is K112262.

When did REFLEX BALLON GUIDE CATHETER receive FDA 510(k) clearance?

REFLEX BALLON GUIDE CATHETER received FDA 510(k) clearance on 2011-11-02, under 510(k) number K112262.

Who is the listed applicant for REFLEX BALLON GUIDE CATHETER?

The FDA 510(k) record lists Reverse Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REFLEX BALLON GUIDE CATHETER?

The FDA product code for REFLEX BALLON GUIDE 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 Reverse Medical Corporation 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.

K133282REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEMK130858REVERSE MEDICAL MICROCATHETERK123803REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEMK122684REVERSE MEDICAL MICROCATHETERK102418REVERSE MEDICAL REPORT GUIDE CATHETER SYSTEMK110055REVERSE MEDICAL REFLEX GUIDE CATHETER

View all 8 devices →

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.

↑