Cardiac Pacemakers, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 76
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
| K093969 | ACUITY BREAK-AWAY GUIDE CATHETER | March 5, 2010 |
| K080154 | ACUITY UNIVERSAL CUTTER | March 20, 2008 |
| K934727 | REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER | January 10, 1994 |
| K920601 | ASTRA T2, ASTRA T4, ASTRA T6 | October 28, 1992 |
| K912379 | PDT CARRYALL TRANSMITTER, VARIOUS MODELS | June 17, 1991 |
| K905674 | LEAD STYLET | January 30, 1991 |
| K900498 | MODIFIED BETATRON IV INSULIN INFUSION SYSTEM | February 23, 1990 |
| K894738 | MODEL 6888 LEAD TUNNELER | September 13, 1989 |
| K890785 | ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE | March 10, 1989 |
| K875147 | TORQUE HEX WRENCH | January 27, 1988 |
| K872774 | BETATRON IV SYSTEM | January 5, 1988 |
| K865013 | ASTRA T2, T4 AND T6 | February 19, 1987 |
| K863046 | ULTRA SOFTWARE MODULE: MODEL 2016 | December 5, 1986 |
| K863045 | PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580 | September 29, 1986 |
| K863000 | ASTRA 2,3,4 AND 6: CHIP REVISION | August 19, 1986 |
| K860585 | ASTRA T2, T3, T4 & T6 MULTIPROGRAM PULSE GENERATOR | July 16, 1986 |
| K860584 | SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN | June 6, 1986 |
| K855171 | TELEMETRY WAND MODEL | January 22, 1986 |
| K852060 | INFUSION SETS MODELS 9120,9121,9125, 9122 & 9123 | June 7, 1985 |
| K842394 | ASTRA 2, ASTRA 3, 4 & 6 | October 17, 1984 |