Medical Device Manufacturer · US , Englewood , CO

Telectronics Pacing Systems, Inc. - FDA 510(k) Cleared Devices

20 submissions · 18 cleared · Since 1989
20
Total
18
Cleared
0
Denied

Telectronics Pacing Systems, Inc. has 18 FDA 510(k) cleared cardiovascular devices. Based in Englewood, US.

Historical record: 18 cleared submissions from 1989 to 1996.

Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Telectronics Pacing Systems, Inc.

20 devices
1-20 of 20
Cleared Jul 15, 1996
MAXIM PF MODELS 033-581/033-590
K961118 · DTB
Cardiovascular · 117d
Cleared Jun 24, 1996
STERILIZATION
K943657 · DTB
Cardiovascular · 698d
Cleared May 12, 1994
BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM
K934899 · DTD
Cardiovascular · 210d
Cleared May 27, 1993
NEW LEAD INTRODUCER KITS, VARIOUS MODELS
K926340 · DYB
Cardiovascular · 161d
Cleared Aug 17, 1992
NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING
K914489 · DTB
Cardiovascular · 314d
Cleared Dec 31, 1991
UNIVERSAL TERMINAL CAP, 3.2MM
K913919 · KFJ
Cardiovascular · 119d
Cleared Oct 23, 1991
UNIPOLAR UPSIZING ADAPTOR
K912773 · DTD
Cardiovascular · 121d
Cleared Aug 28, 1991
100 CM PERMANENT PACING LEAD MODELS
K911273 · DTB
Cardiovascular · 159d
Cleared Feb 25, 1991
BIFURCATED VS-1 TO VS-1 LEAD ADAPTOR
K910112 · DTD
Cardiovascular · 46d
Cleared Jan 18, 1991
OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE
K903186 · DXY
Cardiovascular · 183d
Cleared Jan 08, 1991
LASERDISH POLY UNIPOLAR VENTRI LEAD W/TRAIL TINES
K904741 · DTB
Cardiovascular · 82d
Cleared Nov 08, 1990
LASERDISH SILICONE VENTRICULAR LEAD W/TRAILING TIN
K903221 · DTB
Cardiovascular · 108d
Cleared Aug 08, 1990
LASERDISH POLYURETHANE VENTRICULAR LEAD W/TRAILING
K900645 · DTB
Cardiovascular · 180d
Cleared Jun 12, 1990
VS-1 LEAD EXT. 033-302, 4.75MM 033-260, 033-458
K901402 · DTB
Cardiovascular · 78d
Cleared Apr 10, 1990
UPSIZING LEAD ADAPTERS 5.0MM PEEL-AWAY ADAPTER
K896438 · DTD
Cardiovascular · 152d
Cleared Mar 14, 1990
OPTIMA MPT MODEL 5281E AND MODEL 5282E
K897116 · DXY
Cardiovascular · 78d
Cleared Feb 22, 1990
TELECTRONICS PACING SYSTEMS VS-1 TO 6MM UPSIZING
K895971 · DTD
Cardiovascular · 132d
Cleared Feb 05, 1990
MODIFIED J-STIFFENER WIRE MATERIAL IN LEAD LINES
K897067 · DTB
Cardiovascular · 46d
Cleared Nov 14, 1989
NEW ADHESIVE, PELLETHAN ON POLYURETHANE LEADS-MODI
K893041 · DTB
Cardiovascular · 204d
Cleared Aug 17, 1989
OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR
K894185 · DXY
Cardiovascular · 62d
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