Telectronics Pacing Systems, Inc.
Englewood, CO, US
Telectronics Pacing Systems, Inc. appears in FDA device records in Englewood, CO. FDA records list 20 510(k) clearances between and , 71 PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 20
- PMA records
- 71
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 20 510(k) clearances for Telectronics Pacing Systems, Inc. between 1989 and 1996. The busiest year on record is 1990, with 7. The most recent is 1996, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 2 |
| 1990 | 7 |
| 1991 | 6 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 1 |
| 1996 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K961118 | MAXIM PF MODELS 033-581/033-590 | DTB | Substantially Equivalent - Subject to Tracking Reg. | |
| K943657 | STERILIZATION | DTB | Substantially Equivalent - Subject to Tracking Reg. | |
| K934899 | BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM | DTD | Substantially Equivalent | |
| K926340 | NEW LEAD INTRODUCER KITS, VARIOUS MODELS | DYB | Substantially Equivalent | |
| K914489 | NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING | DTB | Substantially Equivalent | |
| K913919 | UNIVERSAL TERMINAL CAP, 3.2MM | KFJ | Substantially Equivalent | |
| K912773 | UNIPOLAR UPSIZING ADAPTOR | DTD | Substantially Equivalent | |
| K911273 | 100 CM PERMANENT PACING LEAD MODELS | DTB | Substantially Equivalent | |
| K910112 | BIFURCATED VS-1 TO VS-1 LEAD ADAPTOR | DTD | Substantially Equivalent | |
| K903186 | OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE | DXY | Substantially Equivalent | |
| K904741 | LASERDISH POLY UNIPOLAR VENTRI LEAD W/TRAIL TINES | DTB | Substantially Equivalent | |
| K903221 | LASERDISH SILICONE VENTRICULAR LEAD W/TRAILING TIN | DTB | Substantially Equivalent | |
| K900645 | LASERDISH POLYURETHANE VENTRICULAR LEAD W/TRAILING | DTB | Substantially Equivalent | |
| K901402 | VS-1 LEAD EXT. 033-302, 4.75MM 033-260, 033-458 | DTB | Substantially Equivalent | |
| K896438 | UPSIZING LEAD ADAPTERS 5.0MM PEEL-AWAY ADAPTER | DTD | Substantially Equivalent | |
| K897116 | OPTIMA MPT MODEL 5281E AND MODEL 5282E | DXY | Substantially Equivalent | |
| K895971 | TELECTRONICS PACING SYSTEMS VS-1 TO 6MM UPSIZING | DTD | Substantially Equivalent | |
| K897067 | MODIFIED J-STIFFENER WIRE MATERIAL IN LEAD LINES | DTB | Substantially Equivalent | |
| K893041 | NEW ADHESIVE, PELLETHAN ON POLYURETHANE LEADS-MODI | DTB | Substantially Equivalent | |
| K894185 | OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR | DXY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain