FDA 510(k) Application Details - K243436

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K243436
Device Name	Catheter, Percutaneous
Applicant	Basis Medical 4080 McGinnis Ferry Road, Building 300, Suite 304 Alpharetta, GA 30005 US Other 510(k) Applications for this Company
Contact	David Martin 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	11/05/2024
Decision Date	02/28/2025
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