FDA 510(k) Application Details - K243954

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K243954
Device Name	Introducer, Catheter
Applicant	CIRCA Scientific, Inc. 14 Inverness Drive East, Suite H-136 Englewood, CO 80112 US Other 510(k) Applications for this Company
Contact	Alice Ouyang Other 510(k) Applications for this Contact
Regulation Number	870.1340   More FDA Info for this Regulation Number
Classification Product Code	DYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2024
Decision Date	04/24/2025
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