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FDA 510(k)

INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS

K-Number: K011184 · 2001-08-13

Decision Date2001-08-13
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Intratherapeutics, Inc.. It received FDA 510(k) clearance on 2001-08-13 under 510(k) number K011184. 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 INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS?

INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS is a medical device that received FDA 510(k) clearance on 2001-08-13. The listed applicant is Intratherapeutics, Inc.. The 510(k) number is K011184.

When did INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS receive FDA 510(k) clearance?

INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS received FDA 510(k) clearance on 2001-08-13, under 510(k) number K011184.

Who is the listed applicant for INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS?

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

What is the FDA product code for INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS?

The FDA product code for INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS 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 Intratherapeutics, 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.

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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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