FDA 510(k) Application Details - K243184

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K243184
Device Name	Catheter, Percutaneous
Applicant	Strait Access Technologies Holdings 313 Chris Barnard Building, Anzio Road Observatory 7925 Cape Town ZA Other 510(k) Applications for this Company
Contact	Malcolm Applewhite Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	DQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2024
Decision Date	06/25/2025
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