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)

AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX

K-Number: K111704 · 2011-09-09

ApplicantAvinger, Inc.
Decision Date2011-09-09
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX is the device name listed in this FDA 510(k) record. The listed applicant is Avinger, Inc.. It received FDA 510(k) clearance on 2011-09-09 under 510(k) number K111704. 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 AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX?

AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX is a medical device that received FDA 510(k) clearance on 2011-09-09. The listed applicant is Avinger, Inc.. The 510(k) number is K111704.

When did AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX receive FDA 510(k) clearance?

AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX received FDA 510(k) clearance on 2011-09-09, under 510(k) number K111704.

Who is the listed applicant for AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX?

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

What is the FDA product code for AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX?

The FDA product code for AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX 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 Avinger, 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.

K230005Pantheris LV Atherectomy CatheterK230594Tigereye ST CTO-Crossing CatheterK212468Tigereye CTO-Crossing CatheterK212047Pantheris SystemK201330Tigereye CTO-Crossing CatheterK182341Pantheris SV

View all 23 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.

↑