FDA 510(k) Application Details - K983534

Device Classification Name	More FDA Info for this Device
510(K) Number	K983534
Device Name	7F HYDROLYSER THROMBECTOMY CATHETER
Applicant	CORDIS CORP. 14201 N.W. 60TH AVE. MIAMI LAKES, FL 33014 US Other 510(k) Applications for this Company
Contact	ARIEL MACTAVISH Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/09/1998
Decision Date	02/26/1999
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