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FDA 510(k)

ULTRAFLEX EV HEMOSTASIS INTRODUCER

K-Number: K012922 · 2001-09-25

ApplicantSt Jude Medical
Decision Date2001-09-25
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ULTRAFLEX EV HEMOSTASIS INTRODUCER 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 2001-09-25 under 510(k) number K012922. 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 ULTRAFLEX EV HEMOSTASIS INTRODUCER?

ULTRAFLEX EV HEMOSTASIS INTRODUCER is a medical device that received FDA 510(k) clearance on 2001-09-25. The listed applicant is St Jude Medical. The 510(k) number is K012922.

When did ULTRAFLEX EV HEMOSTASIS INTRODUCER receive FDA 510(k) clearance?

ULTRAFLEX EV HEMOSTASIS INTRODUCER received FDA 510(k) clearance on 2001-09-25, under 510(k) number K012922.

Who is the listed applicant for ULTRAFLEX EV HEMOSTASIS INTRODUCER?

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 ULTRAFLEX EV HEMOSTASIS INTRODUCER?

The FDA product code for ULTRAFLEX EV HEMOSTASIS INTRODUCER 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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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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