FDA 510(k) Application Details - K221163

Device Classification Name	More FDA Info for this Device
510(K) Number	K221163
Device Name	Tunnel Crossing Catheter
Applicant	Tractus Vascular, LLC 20 Meridian Road Unit 9B Eatontown, NJ 07724 US Other 510(k) Applications for this Company
Contact	Janet Burpee Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/2022
Decision Date	01/19/2023
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