510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Vascular Insights, LLC

Madison, CT, US

Vascular Insights, LLC appears in FDA device records in Madison, CT. FDA records list 2 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
1
Registered establishments
0

510(k) clearance history

FDA records hold 2 510(k) clearances for Vascular Insights, LLC between 2008 and 2016. The busiest year on record is 2008, with 1. The most recent is 2016, with 1.

Clearances by year, as a table
510(k) clearance decisions for Vascular Insights, LLC, by decision year
YearClearances
20081
20161
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K153502ClariVein ICKRASubstantially Equivalent
K071468CLARIVEIN CATHETERKRASubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1146-2018ClariVein 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.Certain catheters could have a compromised catheter shaft due to a manufacturing defect which could result in some delamination of the catheter shaft including during introduction of the catheter into a vascular access introducer.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain