Arco Medical Products Co.
Walker, MI, US
Arco Medical Products Co. appears in FDA device records in Walker, MI. FDA records list 21 510(k) clearances between and , no 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
- 21
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 21 510(k) clearances for Arco Medical Products Co. between 1976 and 1980. The busiest year on record is 1979, with 7. The most recent is 1980, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1977 | 2 |
| 1978 | 4 |
| 1979 | 7 |
| 1980 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K802588 | MODEL 3003 UNIPOLAR DEMAND CARDIAC GEN. | DXY | Substantially Equivalent | |
| K801806 | EXTERNAL SILASTIC BOOT FOR CARDIAC PULSE | DXY | Substantially Equivalent | |
| K801241 | UNIPOLAR PROGRAMMABLE LITHIUM CARD. GEN. | DXY | Substantially Equivalent | |
| K800837 | PROGRAMMABLE BIPOLAR CARDIAC GENERATOR | DXY | Substantially Equivalent | |
| K800838 | ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN. | DXY | Substantially Equivalent | |
| K800326 | ARCOLITH 3021-CARDIAC PULSE GENERATOR | DXY | Substantially Equivalent | |
| K792299 | ARCOLITH 3020-CARDIAC PULSE GENERATOR | DXY | Substantially Equivalent | |
| K792216 | ARCOLITH 2100-CARDIAC PULSE GENERATOR | DXY | Substantially Equivalent | |
| K791715 | ARCOLITH 2000 | DXY | Substantially Equivalent | |
| K791147 | ARCO PROGAMMABLE PACEMAKER SYSTEM | DXY | Substantially Equivalent | |
| K791165 | ARCOLITH 4000 | DXY | Substantially Equivalent | |
| K790436 | IMPLANTABLE HEART LEAD TERMINAL ADAPTER | DTD | Substantially Equivalent | |
| K790468 | IMPLANTABLE HEART LEAD EXTENDER | DTD | Substantially Equivalent | |
| K782146 | PACEMAKER, MODEL DDP ELECTRONIC CIRCUIT | DXY | Unknown | |
| K780776 | ARCOBIOLITH PACEMAKER MODEL | DXY | Substantially Equivalent | |
| K780307 | CARDIAC MINIGRAPH | DPS | Substantially Equivalent | |
| K780297 | CARDIAC MINISCOPE & MINIGRAPH | DRT | Substantially Equivalent | |
| K771262 | PACEMAKER & CARDIAC LEAD, BIPOLAR | DXY | Substantially Equivalent | |
| K770416 | LEAD, HEART, BUTTERFLY CLAMP | DTB | Substantially Equivalent | |
| K761237 | ELEC. CIR. PACE. MO. LI-2,LI-3,LI-4,LI-5 | DXY | Substantially Equivalent | |
| K760963 | DECUBITUS MATTRESS | IKY | 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