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510(k) K182916

Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr by Lemaitre Vascular — Product Code MJN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2018
Date Received
October 18, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular Occluding, Temporary
Device Class
Class II
Regulation Number
870.4450
Review Panel
CV
Submission Type

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