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FDA 510(k)

VYGON MICRO-ACCESS SAFETY INTRODUCER KIT

K-Number: K051248 · 2005-10-27

ApplicantVygon Corp.
Decision Date2005-10-27
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VYGON MICRO-ACCESS SAFETY INTRODUCER KIT is the device name listed in this FDA 510(k) record. The listed applicant is Vygon Corp.. It received FDA 510(k) clearance on 2005-10-27 under 510(k) number K051248. 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 VYGON MICRO-ACCESS SAFETY INTRODUCER KIT?

VYGON MICRO-ACCESS SAFETY INTRODUCER KIT is a medical device that received FDA 510(k) clearance on 2005-10-27. The listed applicant is Vygon Corp.. The 510(k) number is K051248.

When did VYGON MICRO-ACCESS SAFETY INTRODUCER KIT receive FDA 510(k) clearance?

VYGON MICRO-ACCESS SAFETY INTRODUCER KIT received FDA 510(k) clearance on 2005-10-27, under 510(k) number K051248.

Who is the listed applicant for VYGON MICRO-ACCESS SAFETY INTRODUCER KIT?

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

What is the FDA product code for VYGON MICRO-ACCESS SAFETY INTRODUCER KIT?

The FDA product code for VYGON MICRO-ACCESS SAFETY INTRODUCER KIT is DYB.

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Other records listing Vygon Corp. as applicant

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.

K121105NUTRISAFE 2 FEEDING TUBEK100163NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXXK073493HEPATOSTAT SETK070705MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039K061796HEPATOSTAT SET, MODEL 760XK061250MULTICATH EXPERT

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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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