Arco Medical Products Co.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 21
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K802588 | MODEL 3003 UNIPOLAR DEMAND CARDIAC GEN. | November 19, 1980 |
| K801806 | EXTERNAL SILASTIC BOOT FOR CARDIAC PULSE | September 9, 1980 |
| K801241 | UNIPOLAR PROGRAMMABLE LITHIUM CARD. GEN. | June 30, 1980 |
| K800837 | PROGRAMMABLE BIPOLAR CARDIAC GENERATOR | June 30, 1980 |
| K800838 | ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN. | June 4, 1980 |
| K800326 | ARCOLITH 3021-CARDIAC PULSE GENERATOR | March 17, 1980 |
| K792216 | ARCOLITH 2100-CARDIAC PULSE GENERATOR | November 29, 1979 |
| K792299 | ARCOLITH 3020-CARDIAC PULSE GENERATOR | November 29, 1979 |
| K791715 | ARCOLITH 2000 | September 27, 1979 |
| K791147 | ARCO PROGAMMABLE PACEMAKER SYSTEM | August 3, 1979 |
| K791165 | ARCOLITH 4000 | July 10, 1979 |
| K790436 | IMPLANTABLE HEART LEAD TERMINAL ADAPTER | May 14, 1979 |
| K790468 | IMPLANTABLE HEART LEAD EXTENDER | March 19, 1979 |
| K782146 | PACEMAKER, MODEL DDP ELECTRONIC CIRCUIT | December 27, 1978 |
| K780776 | ARCOBIOLITH PACEMAKER MODEL | October 3, 1978 |
| K780297 | CARDIAC MINISCOPE & MINIGRAPH | May 19, 1978 |
| K780307 | CARDIAC MINIGRAPH | May 19, 1978 |
| K771262 | PACEMAKER & CARDIAC LEAD, BIPOLAR | July 21, 1977 |
| K770416 | LEAD, HEART, BUTTERFLY CLAMP | March 10, 1977 |
| K761237 | ELEC. CIR. PACE. MO. LI-2,LI-3,LI-4,LI-5 | December 21, 1976 |