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FDA 510(k)

ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX

K-Number: K994334 · 2000-05-15

ApplicantDaig Corp.
Decision Date2000-05-15
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX is the device name listed in this FDA 510(k) record. The listed applicant is Daig Corp.. It received FDA 510(k) clearance on 2000-05-15 under 510(k) number K994334. 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 ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX?

ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX is a medical device that received FDA 510(k) clearance on 2000-05-15. The listed applicant is Daig Corp.. The 510(k) number is K994334.

When did ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX receive FDA 510(k) clearance?

ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX received FDA 510(k) clearance on 2000-05-15, under 510(k) number K994334.

Who is the listed applicant for ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX?

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

What is the FDA product code for ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX?

The FDA product code for ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX is DYB.

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Other records listing Daig Corp. as applicant

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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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