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FDA 510(k)

WILTEK BALLOON CHOLANGIOGRAPHY CATHETER

K-Number: K914882 · 1992-01-07

Decision Date1992-01-07
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

WILTEK BALLOON CHOLANGIOGRAPHY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Wiltek Medical, Inc.. It received FDA 510(k) clearance on 1992-01-07 under 510(k) number K914882. 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 WILTEK BALLOON CHOLANGIOGRAPHY CATHETER?

WILTEK BALLOON CHOLANGIOGRAPHY CATHETER is a medical device that received FDA 510(k) clearance on 1992-01-07. The listed applicant is Wiltek Medical, Inc.. The 510(k) number is K914882.

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

WILTEK BALLOON CHOLANGIOGRAPHY CATHETER received FDA 510(k) clearance on 1992-01-07, under 510(k) number K914882.

Who is the listed applicant for WILTEK BALLOON CHOLANGIOGRAPHY CATHETER?

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

What is the FDA product code for WILTEK BALLOON CHOLANGIOGRAPHY CATHETER?

The FDA product code for WILTEK BALLOON CHOLANGIOGRAPHY CATHETER 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 Wiltek Medical, 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.

View all 21 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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