Biotronik, Inc. - FDA 510(k) Cleared Devices
84
Total
66
Cleared
0
Denied
84 devices
Cleared
Mar 19, 2015
BioMonitor
Cardiovascular
99d
Cleared
Dec 05, 2014
Passeo-35 PTA Catheter
Cardiovascular
101d
Cleared
Jun 06, 2014
BIOMONITOR
Cardiovascular
259d
Cleared
Aug 23, 2013
SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL
Cardiovascular
56d
Cleared
Apr 23, 2013
PASSEO-35
Cardiovascular
90d
Cleared
Jan 11, 2013
SELECTRA 7F CATHETERS
Cardiovascular
77d
Cleared
Sep 26, 2011
SELECTRA ACCESSORY KIT
Cardiovascular
89d
Cleared
Sep 26, 2011
SELECTRA SLITTER TOOL
Cardiovascular
28d
Cleared
May 23, 2011
SELECTRA IC-50-60, SELECTRA IC-50-75, SELECTRA IC-90-65, SELECTRA IC-90-75
Cardiovascular
28d
Cleared
Apr 20, 2011
SELECTRA CS LEAD INTRODUCER SYSTEM
Cardiovascular
62d
Cleared
Jul 23, 2010
SCOUTPRO ACS
Cardiovascular
28d
Cleared
Jul 21, 2010
SCOUTPRO HEMOSTATIC VALVE
Cardiovascular
76d
Cleared
Nov 20, 2009
SCOUTPRO 7F LONG CATHETERS
Cardiovascular
30d
Cleared
Apr 01, 2009
PK-141 PATIENT CABLE
Cardiovascular
111d
Cleared
Dec 04, 2008
VISION WIRE CORONARY GUIDEWIRE
Cardiovascular
64d
Cleared
Nov 03, 2008
PASSEO-35 PTA CATHETER
Cardiovascular
33d
Cleared
May 07, 2008
SCOUTPRO CS LEAD INTRODUCER SYSTEM
Cardiovascular
30d
Cleared
Mar 25, 2008
SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED
Cardiovascular
218d
Cleared
Dec 20, 2007
MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS
Cardiovascular
35d
Cleared
Dec 12, 2007
PASSEO 18
Cardiovascular
75d
Cleared
Jul 18, 2007
SCOUTPRO SLITTER TOOL ADVANCED, MODEL 356 552
Cardiovascular
30d
Cleared
Jul 10, 2006
BIOTRONIK ENDOCARDIAL PACING LEADS
Cardiovascular
70d
Cleared
Apr 24, 2006
SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM
Cardiovascular
31d
Cleared
Apr 04, 2006
SCOUTPRO 8F, MODELS 342 262
Cardiovascular
22d
Cleared
Mar 02, 2005
GALEO FOCUS GUIDE WIRE
Cardiovascular
182d
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