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FDA 510(k)

ClariVein IC

K-Number: K153502 · 2016-01-06

ApplicantVascular Insights, LLC
Decision Date2016-01-06
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ClariVein IC is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Insights, LLC. It received FDA 510(k) clearance on 2016-01-06 under 510(k) number K153502. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ClariVein IC?

ClariVein IC is a medical device that received FDA 510(k) clearance on 2016-01-06. The listed applicant is Vascular Insights, LLC. The 510(k) number is K153502.

When did ClariVein IC receive FDA 510(k) clearance?

ClariVein IC received FDA 510(k) clearance on 2016-01-06, under 510(k) number K153502.

Who is the listed applicant for ClariVein IC?

The FDA 510(k) record lists Vascular Insights, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ClariVein IC?

The FDA product code for ClariVein IC is KRA.

Related Devices (Code: KRA)

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.

K261610Verge™ MicrocatheterInstylla, Inc.K260771TruSelect™ 2.6 MicrocatheterBoston Scientific CorporationK250794InVera Infusion DeviceInvera MedicalK243534Micro CatheterSuzhou Zenith Vascular SciTech LimitedK231821XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)Transit Scientific, LLCK231279Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mmAblative Solutions, Inc.

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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