FDA 510(k) Application Details - K181757

Device Classification Name	Device, Percutaneous Retrieval   More FDA Info for this Device
510(K) Number	K181757
Device Name	Device, Percutaneous Retrieval
Applicant	Cook Incorporated 750 Daniels Way; P.O. Box 489 Bloomington, IN 47402 US Other 510(k) Applications for this Company
Contact	Steven Lawrie Other 510(k) Applications for this Contact
Regulation Number	870.5150   More FDA Info for this Regulation Number
Classification Product Code	MMX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/2018
Decision Date	11/06/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review