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)

IVS TUNNELLER DEVICES

K-Number: K073164 · 2008-03-05

ApplicantCovidien UK Manufacturing, Ltd.
Decision Date2008-03-05
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IVS TUNNELLER DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Covidien UK Manufacturing, Ltd.. It received FDA 510(k) clearance on 2008-03-05 under 510(k) number K073164. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IVS TUNNELLER DEVICES?

IVS TUNNELLER DEVICES is a medical device that received FDA 510(k) clearance on 2008-03-05. The listed applicant is Covidien UK Manufacturing, Ltd.. The 510(k) number is K073164.

When did IVS TUNNELLER DEVICES receive FDA 510(k) clearance?

IVS TUNNELLER DEVICES received FDA 510(k) clearance on 2008-03-05, under 510(k) number K073164.

Who is the listed applicant for IVS TUNNELLER DEVICES?

The FDA 510(k) record lists Covidien UK Manufacturing, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IVS TUNNELLER DEVICES?

The FDA product code for IVS TUNNELLER DEVICES is FTL.

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

Related Devices (Code: FTL)

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.

K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim ProductionK253125Parietene™ Flat Sheet MeshMedtronic - Sofradim ProductionK251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc.K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc.K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim ProductionK250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedDavol, 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.

↑