FDA 510(k) Application Details - K243691

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K243691
Device Name	Catheter, Percutaneous
Applicant	Seigla Medical, Inc. 7688 5th Street SE Buffalo, MN 55313 US Other 510(k) Applications for this Company
Contact	Chad Kugler 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	11/26/2024
Decision Date	04/04/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review