DXY · Class III · 21 CFR 870.3610

FDA Product Code DXY: Implantable Pacemaker Pulse-generator

Leading manufacturers include Medtronic Vascular, Intermedics, Inc. and Telectronics, Inc..

461
Total
461
Cleared
80d
Avg days
1976
Since

FDA 510(k) Cleared Implantable Pacemaker Pulse-generator Devices (Product Code DXY)

461 devices
1–24 of 461
Cleared Nov 10, 1999
PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A
K993434
Biotronik, Inc.
Cardiovascular · 29d
Cleared Aug 29, 1997
OPUS S MODEL 4121 AND 4124 PACEMAKERS
K970072
Ela Medical, Inc.
Cardiovascular · 233d
Cleared Mar 04, 1996
PIKOS LP 01, PIKOS LP E01
K945627
Biotronik, Inc.
Cardiovascular · 474d
Cleared Dec 15, 1995
MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)
K953866
Medtronic Vascular
Cardiovascular · 127d
Cleared Dec 15, 1995
ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)
K954092
Medtronic Vascular
Cardiovascular · 127d
Cleared Sep 29, 1995
NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01
K952328
Biotronik, Inc.
Cardiovascular · 134d
Cleared Sep 29, 1995
MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS
K953417
Cook Pacemaker Corp.
Cardiovascular · 113d
Cleared Sep 01, 1995
OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)
K952364
Ela Medical, Inc.
Cardiovascular · 123d
Cleared Jul 12, 1995
PELLETHANE 75D
K940039
Medtronic Vascular
Cardiovascular · 554d
Cleared May 15, 1995
CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER
K946188
Cardiac Control Systems, Inc.
Cardiovascular · 146d
Cleared May 15, 1995
TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES
K950751
Medtronic Vascular
Cardiovascular · 87d
Cleared May 03, 1995
CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER
K950210
Cardiac Control Systems, Inc.
Cardiovascular · 104d
Cleared Aug 30, 1994
PIKOS E 01-B
K941937
Biotronik, Inc.
Cardiovascular · 131d
Cleared May 02, 1994
MINIX/MINIX ST PULSE GENERATORS
K932884
Medtronic Vascular
Cardiovascular · 322d
Cleared Aug 19, 1993
PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER
K923026
Biotronik, GmbH & Co.
Cardiovascular · 422d
Cleared May 14, 1993
CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER
K923868
Cardiac Control Systems, Inc.
Cardiovascular · 284d
Cleared May 14, 1993
MEDTRONIC MINIX & MINIX ST PULSE GENERATORS
K930770
Medtronic Vascular
Cardiovascular · 87d
Cleared Oct 28, 1992
ASTRA T2, ASTRA T4, ASTRA T6
K920601
Cardiac Pacemakers, Inc.
Cardiovascular · 260d
Cleared Mar 17, 1992
INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG
K920530
Intermedics, Inc.
Cardiovascular · 41d
Cleared Mar 16, 1992
SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER
K920157
Schneider Intl., Ltd.
Cardiovascular · 62d
Cleared Feb 26, 1992
PIKOS 01 & PIKOS E 01
K914109
Biotronik, GmbH & Co.
Cardiovascular · 166d
Cleared Oct 16, 1991
MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER
K905403
Cook Pacemaker Corp.
Cardiovascular · 317d
Cleared Aug 22, 1991
MODEL 4220
K913134
Pace Medical
Cardiovascular · 37d
Cleared Jul 26, 1991
MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE
K912545
Pace Medical
Cardiovascular · 46d

About Product Code DXY - Regulatory Context