CLARIVEIN CATHETER— 510(k) K071468

Name: FDA 510(k) clearance K071468
Creator: U.S. Food and Drug Administration
Published: 2008-03-20

Substantially Equivalent

Vascular Insights, LLC

FDA 510(k) clearance K071468 for CLARIVEIN CATHETER, Substantially Equivalent on 2008-03-20. Applicant: Vascular Insights, LLC. Device class: 2.

Clearance details

Applicant: Vascular Insights, LLC
Product code: Code KRA
Device class: Class 2
Regulation: 21 CFR 870.1210
Advisory panel: Cardiovascular
Date received: 2007-05-29
Decision date: 2008-03-20
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Madison, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KRA

view all

K254051 — Extroducer Infusion Catheter System2026-09-11
K261610 — Verge Microcatheter2026-06-11
K260771 — TruSelect 2.6 Microcatheter2026-05-15
K250794 — InVera Infusion Device2026-03-12
K243534 — Micro Catheter2025-07-30

More clearances from Vascular Insights, LLC

view all

K153502 — ClariVein IC2016-01-06

Adverse events under product code KRA

product code KRA

Death: 234
Injury: 1,029
Malfunction: 3,012
Other: 2
Total: 4,277

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K071468

K-number listed on FDA's recall record

Z-1146-2018 — ClariVein IC infusion catheter, Model Number: 65-018-E4S Product Usage: The ClariVein IC infusion catheter is indicated for infusion of physician-specified agents into the peripheral vasculature.Class II·Terminated·Vascular Insights, LLC·20171109

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071468.

Data sourced from openFDA. This site is unofficial and independent of the FDA.