Cleared Special

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

K182916 · Lemaitre Vascular · Cardiovascular

Nov 2018

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K182916 is an FDA 510(k) clearance for the Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr, a Catheter, Intravascular Occluding, Temporary (Class II — Special Controls, product code MJN), submitted by Lemaitre Vascular (Burlington, US). The FDA issued a Cleared decision on November 16, 2018, 29 days after receiving the submission on October 18, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number	K182916 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 18, 2018
Decision Date	November 16, 2018
Days to Decision	29 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF