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)

LIFESTENT NT35 BILIARY STENT SYSTEM

K-Number: K042985 · 2004-12-23

Decision Date2004-12-23
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

LIFESTENT NT35 BILIARY STENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2004-12-23 under 510(k) number K042985. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the LIFESTENT NT35 BILIARY STENT SYSTEM?

LIFESTENT NT35 BILIARY STENT SYSTEM is a medical device that received FDA 510(k) clearance on 2004-12-23. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K042985.

When did LIFESTENT NT35 BILIARY STENT SYSTEM receive FDA 510(k) clearance?

LIFESTENT NT35 BILIARY STENT SYSTEM received FDA 510(k) clearance on 2004-12-23, under 510(k) number K042985.

Who is the listed applicant for LIFESTENT NT35 BILIARY STENT SYSTEM?

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

What is the FDA product code for LIFESTENT NT35 BILIARY STENT SYSTEM?

The FDA product code for LIFESTENT NT35 BILIARY STENT SYSTEM is FGE.

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.

Other records listing Edwards Lifesciences, LLC 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.

View all 122 devices →

Related Devices (Code: FGE)

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.

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.

↑