FDA 510(k) Application Details - K183613

Device Classification Name	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter   More FDA Info for this Device
510(K) Number	K183613
Device Name	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant	PECA Labs 4424 Penn Ave, Suite 201 Pittsburgh, PA 15224 US Other 510(k) Applications for this Company
Contact	Doug Bernstein Other 510(k) Applications for this Contact
Regulation Number	870.3450   More FDA Info for this Regulation Number
Classification Product Code	DSY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/26/2018
Decision Date	04/22/2019
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