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)

AVE BRIDGE STENT SYSTEM

K-Number: K971295 · 1997-11-05

Decision Date1997-11-05
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AVE BRIDGE STENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Arterial Vascular Engineering, Inc.. It received FDA 510(k) clearance on 1997-11-05 under 510(k) number K971295. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AVE BRIDGE STENT SYSTEM?

AVE BRIDGE STENT SYSTEM is a medical device that received FDA 510(k) clearance on 1997-11-05. The listed applicant is Arterial Vascular Engineering, Inc.. The 510(k) number is K971295.

When did AVE BRIDGE STENT SYSTEM receive FDA 510(k) clearance?

AVE BRIDGE STENT SYSTEM received FDA 510(k) clearance on 1997-11-05, under 510(k) number K971295.

Who is the listed applicant for AVE BRIDGE STENT SYSTEM?

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

What is the FDA product code for AVE BRIDGE STENT SYSTEM?

The FDA product code for AVE BRIDGE 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 Arterial Vascular Engineering, 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.

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.

↑