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FDA 510(k)

Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr

K-Number: K182916 · 2018-11-16

ApplicantLemaitre Vascular
Decision Date2018-11-16
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr is a medical device manufactured by Lemaitre Vascular. It received FDA 510(k) clearance on 2018-11-16 under approval number K182916. 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 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr?

Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr is a medical device that received FDA 510(k) clearance on 2018-11-16. It is manufactured by Lemaitre Vascular. The 510(k) number is K182916.

When was Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr approved by the FDA?

Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr received FDA 510(k) clearance on 2018-11-16, under approval number K182916.

What company makes Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr?

Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr is manufactured by Lemaitre Vascular.

What is the FDA product code for Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr?

The FDA product code for Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr is MJN.

Other Devices by Lemaitre Vascular

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Related Devices (Code: MJN)

K160598REBOA Balloon CatheterNuMED, Inc. K153530Bridge Occlusion BalloonSpectranetics, Inc. K152833Pruitt F3-S Polyurethane Carotid ShuntLeMaitre Vascular, Inc. K172790ER-REBOA CatheterPrytime Medical Devices, Inc. K170411ER-REBOA CatheterPrytime Medical Devices, Inc. K160067RenovoCathRenovorx, 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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