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FDA 510(k)

VASCULAR SONO

K-Number: K113196 · 2012-02-06

ApplicantPAJUNK GmbH Medizintechnologie
Decision Date2012-02-06
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VASCULAR SONO is the device name listed in this FDA 510(k) record. The listed applicant is PAJUNK GmbH Medizintechnologie. It received FDA 510(k) clearance on 2012-02-06 under 510(k) number K113196. 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 VASCULAR SONO?

VASCULAR SONO is a medical device that received FDA 510(k) clearance on 2012-02-06. The listed applicant is PAJUNK GmbH Medizintechnologie. The 510(k) number is K113196.

When did VASCULAR SONO receive FDA 510(k) clearance?

VASCULAR SONO received FDA 510(k) clearance on 2012-02-06, under 510(k) number K113196.

Who is the listed applicant for VASCULAR SONO?

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

What is the FDA product code for VASCULAR SONO?

The FDA product code for VASCULAR SONO is DYB.

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Related Devices (Code: DYB)

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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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