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FDA 510(k)

PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION

K-Number: K032206 · 2003-08-08

ApplicantEv3, Inc.
Decision Date2003-08-08
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION is the device name listed in this FDA 510(k) record. The listed applicant is Ev3, Inc.. It received FDA 510(k) clearance on 2003-08-08 under 510(k) number K032206. 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 PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION?

PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION is a medical device that received FDA 510(k) clearance on 2003-08-08. The listed applicant is Ev3, Inc.. The 510(k) number is K032206.

When did PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION receive FDA 510(k) clearance?

PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION received FDA 510(k) clearance on 2003-08-08, under 510(k) number K032206.

Who is the listed applicant for PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION?

The FDA 510(k) record lists Ev3, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION?

The FDA product code for PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION is FGE.

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Related Devices (Code: FGE)

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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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