FDA 510(k) Application Details - K182713

Device Classification Name	More FDA Info for this Device
510(K) Number	K182713
Device Name	Scoreflex PTA Scoring Balloon Catheter
Applicant	OrbusNeich Medical Trading, Inc. 5363 NW 35th Avenue Fort Lauderdale, FL 33309 US Other 510(k) Applications for this Company
Contact	John Pazienza Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2018
Decision Date	06/11/2019
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