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FDA 510(k)

ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX

K-Number: K001346 · 2000-05-24

ApplicantSt. Jude Medical, Inc.
Decision Date2000-05-24
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX is the device name listed in this FDA 510(k) record. The listed applicant is St. Jude Medical, Inc.. It received FDA 510(k) clearance on 2000-05-24 under 510(k) number K001346. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX?

ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX is a medical device that received FDA 510(k) clearance on 2000-05-24. The listed applicant is St. Jude Medical, Inc.. The 510(k) number is K001346.

When did ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX receive FDA 510(k) clearance?

ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX received FDA 510(k) clearance on 2000-05-24, under 510(k) number K001346.

Who is the listed applicant for ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX?

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

What is the FDA product code for ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX?

The FDA product code for ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX is DYB.

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Related Devices (Code: DYB)

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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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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