FDA 510(k)

Pruitt F3-S Polyurethane Carotid Shunt

K-Number: K152833 · 2016-01-21

Decision Date2016-01-21

Product CodeMJN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Pruitt F3-S Polyurethane Carotid Shunt is a medical device manufactured by LeMaitre Vascular, Inc.. It received FDA 510(k) clearance on 2016-01-21 under approval number K152833. The device is classified under product code MJN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pruitt F3-S Polyurethane Carotid Shunt?

Pruitt F3-S Polyurethane Carotid Shunt is a medical device that received FDA 510(k) clearance on 2016-01-21. It is manufactured by LeMaitre Vascular, Inc.. The 510(k) number is K152833.

When was Pruitt F3-S Polyurethane Carotid Shunt approved by the FDA?

Pruitt F3-S Polyurethane Carotid Shunt received FDA 510(k) clearance on 2016-01-21, under approval number K152833.

What company makes Pruitt F3-S Polyurethane Carotid Shunt?

Pruitt F3-S Polyurethane Carotid Shunt is manufactured by LeMaitre Vascular, Inc..

What is the FDA product code for Pruitt F3-S Polyurethane Carotid Shunt?

The FDA product code for Pruitt F3-S Polyurethane Carotid Shunt is MJN.

Other Devices by LeMaitre Vascular, Inc.

K173323AnastoClip GC Closure System K183513XenoSure Dura Biologic Patch K212894PhasTIPP PMA N16837Tissue graft of 6mm and greater PMA P020049Tissue graft of 6mm and greater

Related Devices (Code: MJN)

K160598REBOA Balloon CatheterNuMED, Inc. K153530Bridge Occlusion BalloonSpectranetics, Inc. K172790ER-REBOA CatheterPrytime Medical Devices, Inc. K170411ER-REBOA CatheterPrytime Medical Devices, Inc. K160067RenovoCathRenovorx, Inc. K182916Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 FrLemaitre Vascular

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.