Cook Pacemaker Corp.
Mchenry, IL, US
Cook Pacemaker Corp. appears in FDA device records in Mchenry, IL. FDA records list 34 510(k) clearances between and , 11 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
- 34
- PMA records
- 11
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 34 510(k) clearances for Cook Pacemaker Corp. between 1981 and 1997. The busiest year on record is 1981, with 8. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 8 |
| 1982 | 3 |
| 1983 | 4 |
| 1984 | 4 |
| 1985 | 6 |
| 1986 | 4 |
| 1991 | 1 |
| 1992 | 1 |
| 1995 | 1 |
| 1996 | 1 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K970690 | LOCKING STYLET 2 | DQX | Substantially Equivalent | |
| K961992 | NEEDLE'S EYE SNARE | DXE | Substantially Equivalent | |
| K953417 | MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS | DXY | Substantially Equivalent - Subject to Tracking Reg. | |
| K915188 | MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD | DTB | Unknown | |
| K905403 | MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER | DXY | Substantially Equivalent | |
| K863582 | MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER) | DXY | Substantially Equivalent | |
| K861559 | SERIES (T) PROGRAMMABLE CARDIAC PULSE GENERATORS | DXY | Substantially Equivalent | |
| K860466 | MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN. | DXY | Substantially Equivalent | |
| K860202 | MODEL 327D, SERIES R UNIPOLAR CARDIAC PULSE GENER. | DXY | Substantially Equivalent | |
| K854919 | BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY | DXY | Substantially Equivalent | |
| K854132 | COOK PACEMAKER 332T, SERIES R BIPOLAR CARDIAC PULS | DXY | Substantially Equivalent | |
| K853651 | COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENER | DXY | Substantially Equivalent | |
| K853590 | COOK PACEMAKER CORP. 327T, SERIES R UNIPOLAR CARDI | DXY | Substantially Equivalent | |
| K851699 | COOK PACEMAKER CORP. 332T BIPOLAR CARDIAC PULSE GE | DXY | Substantially Equivalent | |
| K850656 | COOK 331T UNIPOLAR CARDIAC PULSE GENERATOR W/TELEM | DXY | Substantially Equivalent | |
| K843001 | COOK PACEMAKER CORP. 116 BIOPOLAR CARDI | Unknown | ||
| K841983 | COOK PACEMAKER 216 BIPOLAR CARDIAC - | DXY | Substantially Equivalent | |
| K841928 | COOK PACEMAKER 215 UNIPOLAR CARDIAC- | DXY | Substantially Equivalent | |
| K842081 | COOK PACEMAKER CORP. 115 UNIPOLAR CARDI | DXY | Substantially Equivalent | |
| K832893 | MODEL 329T PROGRAMMABLE, BIPOLAR CARDI | DXY | Substantially Equivalent | |
| K832255 | MODEL F UNIPOLAR ENDOCARDIAL LEAD- | DTB | Substantially Equivalent | |
| K832245 | UNIPOLAR-E ENDOCARDIAL TINED LEAD | DTB | Substantially Equivalent | |
| K832052 | MODEL 327T UNIPOLAR CARDIAC PULSE GEN | DXY | Substantially Equivalent | |
| K822904 | MODEL 325D UNIPOLAR CARDIAC PULSE GEN | DXY | Substantially Equivalent | |
| K822652 | JAIN INSULATING BOOT MODEL 225B | DXY | Substantially Equivalent | |
| K821147 | COOK #326T PROGRAM/TELEMETRY BIPOLAR | DXY | Substantially Equivalent | |
| K812832 | MODEL 325C UNIPOLAR CARDIAC PULSE GEN. | DXY | Substantially Equivalent | |
| K812358 | MODEL 325T PROGRAMMABLE PULSE GENERATOR | DXY | Substantially Equivalent | |
| K811879 | MODEL A UNIPOLAR ENDOCARDIAL LEAD | DTB | Substantially Equivalent | |
| K811878 | MODEL B BIPOLAR ENDOCARDIAL LEAD | DTB | Substantially Equivalent | |
| K811877 | MODEL C UNIPOLAR ENDOCARDIAL LEAD | DTB | Substantially Equivalent | |
| K811876 | MODEL D BIPOLAR ENDOCARDIAL LEAD | DTB | Substantially Equivalent | |
| K810885 | #326 PROGRAMMABLE CARD. PULSE GENERATOR | DXY | Substantially Equivalent | |
| K810884 | #325 PROGRAMMABLE CARD. PULSE GENERATOR | 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