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FDA 510(k)

BALLOON DILATION CATHETER

K-Number: K935094 · 1995-01-24

ApplicantWilson-Cook Medical, Inc.
Decision Date1995-01-24
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BALLOON DILATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 1995-01-24 under 510(k) number K935094. 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 BALLOON DILATION CATHETER?

BALLOON DILATION CATHETER is a medical device that received FDA 510(k) clearance on 1995-01-24. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K935094.

When did BALLOON DILATION CATHETER receive FDA 510(k) clearance?

BALLOON DILATION CATHETER received FDA 510(k) clearance on 1995-01-24, under 510(k) number K935094.

Who is the listed applicant for BALLOON DILATION CATHETER?

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

What is the FDA product code for BALLOON DILATION CATHETER?

The FDA product code for BALLOON DILATION CATHETER 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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