FDA 510(k) Applications for Medical Device Product Code "KNQ"
(Dilator, Esophageal)

FDA 510(k) Number Applicant Device Name Decision Date
K983373 B. BRAUN/MCGAW IMPACT BALLOON DILATION CATHETER 06/22/1999
K961438 BOSTON SCIENTIFIC CORP. BALLON DILATATION CATHETER 07/31/1996
K971320 BOSTON SCIENTIFIC CORP. CRE BALLOON DILATATION CATHETER 10/09/1997
K122924 BOSTON SCIENTIFIC CORP. CRE FIXED WIRE BALLON DILATION CATHETER 10/24/2012
K974788 BOSTON SCIENTIFIC CORP. CRE(TM) BALLOON DILATATION CATHETER 03/20/1998
K061787 BOSTON SCIENTIFIC CORP. MAXFORCE TTS SINGLE-USE BALLOON DILATOR 09/21/2006
K033936 C.R. BARD, INC. BARD ELIMINATOR PET BALLOON DILATORS 01/14/2004
K061937 COOK ENDOSCOPY COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON 12/01/2006
K090183 COOK ENDOSCOPY HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON 09/25/2009
K993720 CORDIS CORP. CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER 01/18/2000
K023907 CORDIS CORP. CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER 12/18/2002
K043605 CORDIS EUROPA, N.V. INSCOPE 3-STAGE BALLOON DILATOR 02/04/2005
K060302 CORDIS EUROPA, N.V. INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED 04/11/2006
K093236 ETHICON ENDO-SURGERY, INC. ETHICON ENDO-SURGERYOPTICAL DILATOR 11/10/2009
K031147 ETHICON ENDO-SURGERY, INC. OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR 01/12/2004
K002363 MEDOVATIONS, INC. MEDOVATIONS ESOPHAGEAL DILATOR 11/01/2000
K990935 PILLING WECK SURGICAL JACKSON ESOPHAGEAL DILATOR 05/17/1999
K082995 SAFESTITCH MEDICAL SMART DILATOR 02/06/2009
K971615 TRI-MED SPECIALTIES, INC. PATTISON ESOPHAGEAL DILATOR 07/24/1997


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