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)

ARTECH ARDENT IV - TYPE CLYLINDER IMPLANT

K-Number: K911735 · 1992-03-05

ApplicantArtech Corp.
Decision Date1992-03-05
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ARTECH ARDENT IV - TYPE CLYLINDER IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Artech Corp.. It received FDA 510(k) clearance on 1992-03-05 under 510(k) number K911735. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTECH ARDENT IV - TYPE CLYLINDER IMPLANT?

ARTECH ARDENT IV - TYPE CLYLINDER IMPLANT is a medical device that received FDA 510(k) clearance on 1992-03-05. The listed applicant is Artech Corp.. The 510(k) number is K911735.

When did ARTECH ARDENT IV - TYPE CLYLINDER IMPLANT receive FDA 510(k) clearance?

ARTECH ARDENT IV - TYPE CLYLINDER IMPLANT received FDA 510(k) clearance on 1992-03-05, under 510(k) number K911735.

Who is the listed applicant for ARTECH ARDENT IV - TYPE CLYLINDER IMPLANT?

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

What is the FDA product code for ARTECH ARDENT IV - TYPE CLYLINDER IMPLANT?

The FDA product code for ARTECH ARDENT IV - TYPE CLYLINDER IMPLANT is DZE.

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 Artech Corp. 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 8 devices →

Related Devices (Code: DZE)

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.

↑