FDA 510(k) Application Details - K240775

Device Classification Name	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene   More FDA Info for this Device
510(K) Number	K240775
Device Name	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Applicant	TamaBio #402 2-2-18 Sakai Mushashino-shi Tokyo 180-0022 JP Other 510(k) Applications for this Company
Contact	Tetsuya Nagao Other 510(k) Applications for this Contact
Regulation Number	870.3470   More FDA Info for this Regulation Number
Classification Product Code	DXZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/21/2024
Decision Date	04/18/2025
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