Baylis Medical Co., Inc. - FDA 510(k) Cleared Devices
28
Total
28
Cleared
0
Denied
10 devices
Cleared
Jan 24, 2013
SUREFLEX STEERABLE GUIDING SHEATH KIT
Cardiovascular
122d
Cleared
Apr 01, 2011
TORFLEX TRANSSEPTAL GUIDING SHEATH
Cardiovascular
178d
Cleared
Jul 28, 2010
POWERWIRE RADIOFREQUENCY GUIDEWIRE
Cardiovascular
49d
Cleared
Jul 16, 2010
LEV-OR DILATION CATHETER OTW
Cardiovascular
86d
Cleared
May 28, 2008
NRG TRANSSEPTAL NEEDLE
Cardiovascular
183d
Cleared
Mar 30, 2006
RF TUNNELER WIRE
Cardiovascular
281d
Cleared
Dec 10, 2003
TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75
Cardiovascular
169d
Cleared
Dec 31, 2002
BMC CATHETER CONNECTOR CABLE, MODEL RFP-101
Cardiovascular
85d
Cleared
Mar 07, 2002
BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145
Cardiovascular
86d
Cleared
Feb 01, 2001
BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER,...
Cardiovascular
734d