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FDA 510(k)

Quantum TTC Biliary Balloon Dilator

K-Number: K171223 · 2017-06-16

Decision Date2017-06-16
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Quantum TTC Biliary Balloon Dilator 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 2017-06-16 under 510(k) number K171223. 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 Quantum TTC Biliary Balloon Dilator?

Quantum TTC Biliary Balloon Dilator is a medical device that received FDA 510(k) clearance on 2017-06-16. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K171223.

When did Quantum TTC Biliary Balloon Dilator receive FDA 510(k) clearance?

Quantum TTC Biliary Balloon Dilator received FDA 510(k) clearance on 2017-06-16, under 510(k) number K171223.

Who is the listed applicant for Quantum TTC Biliary Balloon Dilator?

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 Quantum TTC Biliary Balloon Dilator?

The FDA product code for Quantum TTC Biliary Balloon Dilator is FGE.

Other records listing Wilson-Cook 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 34 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.