FDA 510(k) Application Details - K181031

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K181031
Device Name	Introducer, Catheter
Applicant	Pressure Products Medical Device Manufacturing LLC 1 School Street Morton, PA 19070 US Other 510(k) Applications for this Company
Contact	Andrew Armour Other 510(k) Applications for this Contact
Regulation Number	870.1340   More FDA Info for this Regulation Number
Classification Product Code	DYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/18/2018
Decision Date	10/26/2018
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