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FDA 510(k)

MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F)

K-Number: K023447 · 2002-10-31

ApplicantSt Jude Medical
Decision Date2002-10-31
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F) is the device name listed in this FDA 510(k) record. The listed applicant is St Jude Medical. It received FDA 510(k) clearance on 2002-10-31 under 510(k) number K023447. 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 MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F)?

MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F) is a medical device that received FDA 510(k) clearance on 2002-10-31. The listed applicant is St Jude Medical. The 510(k) number is K023447.

When did MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F) receive FDA 510(k) clearance?

MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F) received FDA 510(k) clearance on 2002-10-31, under 510(k) number K023447.

Who is the listed applicant for MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F)?

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

What is the FDA product code for MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F)?

The FDA product code for MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F) 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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