FDA 510(k) Application Details - K180769

Device Classification Name	Implanted Subcutaneous Securement Catheter   More FDA Info for this Device
510(K) Number	K180769
Device Name	Implanted Subcutaneous Securement Catheter
Applicant	Interrad Medical Inc 181 Cheshire Lane, Suite 100 Plymouth, MN 55441 US Other 510(k) Applications for this Company
Contact	Denise Lenz Other 510(k) Applications for this Contact
Regulation Number	880.5970   More FDA Info for this Regulation Number
Classification Product Code	OKC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/23/2018
Decision Date	06/26/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review