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

FDA 510(k) Number Applicant Device Name Decision Date
K895098 ANNEX MEDICAL, INC. BIOPSY FORCEPS 10/30/1989
K921401 ANNEX MEDICAL, INC. BIOPSY FORCEPS 10/21/1992
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
K882383 CIVCO MEDICAL INSTRUMENTS CO., INC. MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES 11/28/1988
K883723 COOK, INC. FLEXIBLE MYOCARDIAL BIOPSY FORCEPS 12/05/1988
K810849 CORDIS CORP. CORDIS BIOPSY FORCEPS 04/17/1981
K920289 CORDIS CORP. CORDIS BIPAL 7 BIOPSY FORCEPS 03/30/1992
K932788 CORDIS CORP. CORDIS BIPAL 7 BIOPSY FORCEPS WITH A INLINE HANDLE 09/01/1993
K914567 CORDIS CORP. CORDIS BIPAL BIOPSY FORCEPS 12/18/1991
K890453 DLP, INC. REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES 03/31/1989
K170726 Fehling Instruments GmbH & Co. KG Biopsy Forceps 06/02/2017
K881412 FEHLING MEDIZINTECHNIK GMBH MYOCARD BIOPSY FORCEP 09/08/1988
K974175 HEARTPORT, INC. HEARTPORT ENDOAORTIC CLAMP CATHETER 12/16/1997
K870186 MANSFIELD SCIENTIFIC, INC. ENDOMYOCARDIAL BIOPSY DEVICE 02/20/1987
K991486 MEDCANICA, INC. ULTRA-CBX 11/05/1999
K901300 PORTLYN CORP. BIOPSY FORCEPS 06/29/1990
K951447 PORTLYN CORP. DYNABITE CARDIOVASCULAR BIOPSY FORCEPS 07/27/1995
K072051 SCHOLTEN SURGICAL INSTRUMENTS, INC. NOVATOME, MODEL: SU101-50 10/03/2007
K910840 VASCULAR PRODUCTS, INC. VASCULAR BIOPSY FORCEPS 07/15/1991


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