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)

ESTECH EASYFLOW CANNULA WITH GUIDEWIRE

K-Number: K091542 · 2009-10-20

ApplicantEndoscopic Technologies, Inc. D/B/A Estech
Decision Date2009-10-20
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ESTECH EASYFLOW CANNULA WITH GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Endoscopic Technologies, Inc. D/B/A Estech. It received FDA 510(k) clearance on 2009-10-20 under 510(k) number K091542. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESTECH EASYFLOW CANNULA WITH GUIDEWIRE?

ESTECH EASYFLOW CANNULA WITH GUIDEWIRE is a medical device that received FDA 510(k) clearance on 2009-10-20. The listed applicant is Endoscopic Technologies, Inc. D/B/A Estech. The 510(k) number is K091542.

When did ESTECH EASYFLOW CANNULA WITH GUIDEWIRE receive FDA 510(k) clearance?

ESTECH EASYFLOW CANNULA WITH GUIDEWIRE received FDA 510(k) clearance on 2009-10-20, under 510(k) number K091542.

Who is the listed applicant for ESTECH EASYFLOW CANNULA WITH GUIDEWIRE?

The FDA 510(k) record lists Endoscopic Technologies, Inc. D/B/A Estech as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ESTECH EASYFLOW CANNULA WITH GUIDEWIRE?

The FDA product code for ESTECH EASYFLOW CANNULA WITH GUIDEWIRE is DWF.

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 Endoscopic Technologies, Inc. D/B/A Estech 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.

K113475ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEMK110913ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORYK100224ESTECH COBRA BIPOLSR IIK091350ESTECH HAWKEYE INTRODUCER SYSTEMS

Related Devices (Code: DWF)

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.

K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc.K250937Venous Return CannulaeLivaNova USA, Inc.K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart ReactorsK253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc.K253671Dual Stage Venous CannulaeSorin Group Italia S.R.L.K253998Clearview Intracoronary ShuntsMedtronic, Inc.

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.

↑