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FDA 510(k)

SENTRY EXPANDING INTRODUCER SHEATH (EIS)

K-Number: K000545 · 2000-05-02

ApplicantApplied Medical Resources
Decision Date2000-05-02
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SENTRY EXPANDING INTRODUCER SHEATH (EIS) is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources. It received FDA 510(k) clearance on 2000-05-02 under 510(k) number K000545. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENTRY EXPANDING INTRODUCER SHEATH (EIS)?

SENTRY EXPANDING INTRODUCER SHEATH (EIS) is a medical device that received FDA 510(k) clearance on 2000-05-02. The listed applicant is Applied Medical Resources. The 510(k) number is K000545.

When did SENTRY EXPANDING INTRODUCER SHEATH (EIS) receive FDA 510(k) clearance?

SENTRY EXPANDING INTRODUCER SHEATH (EIS) received FDA 510(k) clearance on 2000-05-02, under 510(k) number K000545.

Who is the listed applicant for SENTRY EXPANDING INTRODUCER SHEATH (EIS)?

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

What is the FDA product code for SENTRY EXPANDING INTRODUCER SHEATH (EIS)?

The FDA product code for SENTRY EXPANDING INTRODUCER SHEATH (EIS) is GCJ.

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Related Devices (Code: GCJ)

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Official Source

View on FDA Database →

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

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