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FDA 510(k)

PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM

K-Number: K032137 · 2003-09-17

ApplicantCordis Corp.
Decision Date2003-09-17
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp.. It received FDA 510(k) clearance on 2003-09-17 under 510(k) number K032137. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM?

PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM is a medical device that received FDA 510(k) clearance on 2003-09-17. The listed applicant is Cordis Corp.. The 510(k) number is K032137.

When did PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM receive FDA 510(k) clearance?

PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM received FDA 510(k) clearance on 2003-09-17, under 510(k) number K032137.

Who is the listed applicant for PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM?

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

What is the FDA product code for PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM?

The FDA product code for PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM 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 Cordis Corp. 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.

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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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