FDA 510(k) Application Details - K181056

Device Classification Name	Catheter, Recording, Electrode, Reprocessed   More FDA Info for this Device
510(K) Number	K181056
Device Name	Catheter, Recording, Electrode, Reprocessed
Applicant	Stryker Sustainability Solutions 1810 W. Drake Drive Tempe, AZ 85283 US Other 510(k) Applications for this Company
Contact	Mia McCorkel Other 510(k) Applications for this Contact
Regulation Number	870.1220   More FDA Info for this Regulation Number
Classification Product Code	NLH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/20/2018
Decision Date	01/24/2019
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