FDA 510(k) Applications for Medical Device Product Code "DXF"
(Catheter, Septostomy)

FDA 510(k) Number Applicant Device Name Decision Date
K990284 BAYLIS MEDICAL CO., INC. BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE 02/01/2001
K073326 BAYLIS MEDICAL CO., INC. NRG TRANSSEPTAL NEEDLE 05/28/2008
K031949 BAYLIS MEDICAL CO., INC. TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75 12/10/2003
K150709 BAYLIS MEDICAL COMPANY INC. ProTrack RF Anchor Wire 06/17/2015
K801031 COOK, INC. BLADE SEPTOSTOMY CATHETER 07/28/1980
K001804 NUMED, INC. NUMED Z-5 ATRIOSEPTOSTOMY CATHETER 07/12/2000
K011557 NUMED, INC. PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS 07/12/2001
K860806 TARGET THERAPEUTICS REGULATED PRESSURE INJECTOR 03/31/1986


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