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FDA 510(k)

DRAINAGE STENT

K-Number: K834468 · 1984-04-20

ApplicantMicrovasive
Decision Date1984-04-20
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DRAINAGE STENT is the device name listed in this FDA 510(k) record. The listed applicant is Microvasive. It received FDA 510(k) clearance on 1984-04-20 under 510(k) number K834468. 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 DRAINAGE STENT?

DRAINAGE STENT is a medical device that received FDA 510(k) clearance on 1984-04-20. The listed applicant is Microvasive. The 510(k) number is K834468.

When did DRAINAGE STENT receive FDA 510(k) clearance?

DRAINAGE STENT received FDA 510(k) clearance on 1984-04-20, under 510(k) number K834468.

Who is the listed applicant for DRAINAGE STENT?

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

What is the FDA product code for DRAINAGE STENT?

The FDA product code for DRAINAGE STENT 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 Microvasive 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 18 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.

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