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FDA 510(k)

SENTINOL NITINOL BILLARY STENT SYSTEM

K-Number: K032025 · 2003-09-25

Decision Date2003-09-25
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

SENTINOL NITINOL BILLARY STENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2003-09-25 under 510(k) number K032025. 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 SENTINOL NITINOL BILLARY STENT SYSTEM?

SENTINOL NITINOL BILLARY STENT SYSTEM is a medical device that received FDA 510(k) clearance on 2003-09-25. The listed applicant is Boston Scientific Corp. The 510(k) number is K032025.

When did SENTINOL NITINOL BILLARY STENT SYSTEM receive FDA 510(k) clearance?

SENTINOL NITINOL BILLARY STENT SYSTEM received FDA 510(k) clearance on 2003-09-25, under 510(k) number K032025.

Who is the listed applicant for SENTINOL NITINOL BILLARY STENT SYSTEM?

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

What is the FDA product code for SENTINOL NITINOL BILLARY STENT SYSTEM?

The FDA product code for SENTINOL NITINOL BILLARY STENT 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 Boston Scientific 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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