Telectronics Pacing Systems, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 20
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K961118 | MAXIM PF MODELS 033-581/033-590 | July 15, 1996 |
| K943657 | STERILIZATION | June 24, 1996 |
| K934899 | BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM | May 12, 1994 |
| K926340 | NEW LEAD INTRODUCER KITS, VARIOUS MODELS | May 27, 1993 |
| K914489 | NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING | August 17, 1992 |
| K913919 | UNIVERSAL TERMINAL CAP, 3.2MM | December 31, 1991 |
| K912773 | UNIPOLAR UPSIZING ADAPTOR | October 23, 1991 |
| K911273 | 100 CM PERMANENT PACING LEAD MODELS | August 28, 1991 |
| K910112 | BIFURCATED VS-1 TO VS-1 LEAD ADAPTOR | February 25, 1991 |
| K903186 | OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE | January 18, 1991 |
| K904741 | LASERDISH POLY UNIPOLAR VENTRI LEAD W/TRAIL TINES | January 8, 1991 |
| K903221 | LASERDISH SILICONE VENTRICULAR LEAD W/TRAILING TIN | November 8, 1990 |
| K900645 | LASERDISH POLYURETHANE VENTRICULAR LEAD W/TRAILING | August 8, 1990 |
| K901402 | VS-1 LEAD EXT. 033-302, 4.75MM 033-260, 033-458 | June 12, 1990 |
| K896438 | UPSIZING LEAD ADAPTERS 5.0MM PEEL-AWAY ADAPTER | April 10, 1990 |
| K897116 | OPTIMA MPT MODEL 5281E AND MODEL 5282E | March 14, 1990 |
| K895971 | TELECTRONICS PACING SYSTEMS VS-1 TO 6MM UPSIZING | February 22, 1990 |
| K897067 | MODIFIED J-STIFFENER WIRE MATERIAL IN LEAD LINES | February 5, 1990 |
| K893041 | NEW ADHESIVE, PELLETHAN ON POLYURETHANE LEADS-MODI | November 14, 1989 |
| K894185 | OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR | August 17, 1989 |