FDA 510(k) Application Details - K180558

Device Classification Name	Transducer, Pressure, Catheter Tip   More FDA Info for this Device
510(K) Number	K180558
Device Name	Transducer, Pressure, Catheter Tip
Applicant	St. Jude Medical (now part of Abbott Medical) One St. Jude Medical Drive St. Paul, MN 55117 US Other 510(k) Applications for this Company
Contact	Josh Johnson Other 510(k) Applications for this Contact
Regulation Number	870.2870   More FDA Info for this Regulation Number
Classification Product Code	DXO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/01/2018
Decision Date	03/28/2018
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