Medical Device Manufacturer · US , Palm Harbor , FL

Oscor, Inc.

49 submissions · 46 cleared · Since 1979
49
Total
46
Cleared
0
Denied

Oscor, Inc. — FDA 510(k) Submissions

Oscor, Inc. has submitted 49 FDA 510(k) premarket notifications since 1979, of which 46 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Permanent Pacemaker Electrode, Introducer, Catheter, Pacemaker Lead Adaptor, Electrode, Pacemaker, Temporary, Trocar . Use the specialty filter in the sidebar to narrow results.

49 devices
1–25 of 49
Breezeway II
K210627 · DYB Introducer, Catheter · Cardiovascular
Jun 2021 93d
Destino Reach
K151951 · DYB Introducer, Catheter · Cardiovascular
Sep 2015 69d
IS4/DF4 Port Plug
K143463 · DTD Pacemaker Lead Adaptor · Cardiovascular
Mar 2015 105d
INTRODUCER, MODEL ADELANTE MAGNUM
K140917 · DYB Introducer, Catheter · Cardiovascular
Jul 2014 90d
DESTINO TWIST, STEERABLE GUIDING SHEATH
K140406 · DYB Introducer, Catheter · Cardiovascular
Apr 2014 58d
INTRODUCER SETS, MODEL ADELANTE RADIAL
K130633 · DYB Introducer, Catheter · Cardiovascular
Feb 2014 339d
SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE
K130843 · DRC Trocar · Cardiovascular
Jan 2014 287d
GUIDEWIRE, PURSUER SERIES
K130104 · DQX Wire, Guide, Catheter · Cardiovascular
Jun 2013 149d
DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY
K122958 · DYB Introducer, Catheter · Cardiovascular
Dec 2012 79d
STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO
K122960 · DYB Introducer, Catheter · Cardiovascular
Dec 2012 79d
INTRODUCER SET, MODEL ADELANTE-S SERIES
K122084 · DYB Introducer, Catheter · Cardiovascular
Aug 2012 44d
STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO
K120459 · DYB Introducer, Catheter · Cardiovascular
Jun 2012 135d
DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY
K101497 · DYB Introducer, Catheter · Cardiovascular
Oct 2010 141d
ANGIOGRAPHIC CATHETER, MODEL ANGIOS
K092118 · DQO Catheter, Intravascular,... · Cardiovascular
Jan 2010 183d
MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S
K090114 · DYB Introducer, Catheter · Cardiovascular
Jun 2009 134d
SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE
K081986 · DRC Trocar · Cardiovascular
Nov 2008 123d
OCCLUSION BALLOON CATHETER, MODEL VENOS
K081052 · DYG Catheter, Flow Directed · Cardiovascular
Jun 2008 65d
TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM)
K072770 · LDF Electrode, Pacemaker,... · Cardiovascular
Jan 2008 116d
INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S
K073100 · DYB Introducer, Catheter · Cardiovascular
Nov 2007 28d
ELECTRODE/EXTENSION CABLES, MODELS ATAR
K070926 · IKD Cable, Electrode · Physical Medicine
Jun 2007 65d
PERMANENT PACING LEAD, MODEL PY2
K041809 · DTB Permanent Pacemaker... · Cardiovascular
Aug 2004 31d
PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU
K040569 · DTB Permanent Pacemaker... · Cardiovascular
Apr 2004 34d
PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV
K031164 · DTD Pacemaker Lead Adaptor · Cardiovascular
Jun 2003 66d
PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB
K024053 · DTB Permanent Pacemaker... · Cardiovascular
Jan 2003 53d
PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR
K024156 · DTD Pacemaker Lead Adaptor · Cardiovascular
Jan 2003 28d
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