FDA 510(k) Applications for Medical Device Product Code "DWZ"
(Device, Biopsy, Endomyocardial)

FDA 510(k) Number Applicant Device Name Decision Date
K010473 ATC TECHNOLOGIES, INC. SPARROWHAWK DISPOSABLE 06/06/2001
K000409 BOSTON SCIENTIFIC CORP. MODIFICATION TO T-REX BIOPSY FORCEPS 02/28/2000
K973818 BOSTON SCIENTIFIC CORP. T-REX BIOPSY FORCEPS 12/16/1997
K170726 Fehling Instruments GmbH & Co. KG Biopsy Forceps 06/02/2017
K974175 HEARTPORT, INC. HEARTPORT ENDOAORTIC CLAMP CATHETER 12/16/1997
K991486 MEDCANICA, INC. ULTRA-CBX 11/05/1999
K072051 SCHOLTEN SURGICAL INSTRUMENTS, INC. NOVATOME, MODEL: SU101-50 10/03/2007


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