Company ยท US
Cook Pacemaker Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 1997. Name variants (Inc, Corp, punctuation) are merged.
34510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 20, 1997 | K970690 | LOCKING STYLET 2 Cook Pacemaker Corp. | DQX |
| Dec 27, 1996 | K961992 | NEEDLE'S EYE SNARE Cook Pacemaker Corp. | DXE |
| Sep 29, 1995 | K953417 | MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS Cook Pacemaker Corp. | DXY |
| Sep 11, 1992 | K915188 | MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD Cook Pacemaker Corp. | DTB |
| Oct 16, 1991 | K905403 | MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER Cook Pacemaker Corp. | DXY |
| Oct 8, 1986 | K863582 | MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER) Cook Pacemaker Corp. | DXY |
| May 9, 1986 | K861559 | SERIES (T) PROGRAMMABLE CARDIAC PULSE GENERATORS Cook Pacemaker Corp. | DXY |
| Feb 24, 1986 | K860466 | MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN. Cook Pacemaker Corp. | DXY |
| Feb 24, 1986 | K860202 | MODEL 327D, SERIES R UNIPOLAR CARDIAC PULSE GENER. Cook Pacemaker Corp. | DXY |
| Dec 19, 1985 | K854919 | BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY Cook Pacemaker Corp. | DXY |
| Dec 3, 1985 | K854132 | COOK PACEMAKER 332T, SERIES R BIPOLAR CARDIAC PULS Cook Pacemaker Corp. | DXY |
| Oct 23, 1985 | K853651 | COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENER Cook Pacemaker Corp. | DXY |
| Oct 23, 1985 | K853590 | COOK PACEMAKER CORP. 327T, SERIES R UNIPOLAR CARDI Cook Pacemaker Corp. | DXY |
| May 16, 1985 | K851699 | COOK PACEMAKER CORP. 332T BIPOLAR CARDIAC PULSE GE Cook Pacemaker Corp. | DXY |
| Mar 1, 1985 | K850656 | COOK 331T UNIPOLAR CARDIAC PULSE GENERATOR W/TELEM Cook Pacemaker Corp. | DXY |
| Jul 30, 1984 | K843001 | COOK PACEMAKER CORP. 116 BIOPOLAR CARDI Cook Pacemaker Corp. | |
| Jul 11, 1984 | K841983 | COOK PACEMAKER 216 BIPOLAR CARDIAC - Cook Pacemaker Corp. | DXY |
| Jul 11, 1984 | K841928 | COOK PACEMAKER 215 UNIPOLAR CARDIAC- Cook Pacemaker Corp. | DXY |
| Jul 6, 1984 | K842081 | COOK PACEMAKER CORP. 115 UNIPOLAR CARDI Cook Pacemaker Corp. | DXY |
| Oct 4, 1983 | K832893 | MODEL 329T PROGRAMMABLE, BIPOLAR CARDI Cook Pacemaker Corp. | DXY |
| Aug 12, 1983 | K832255 | MODEL F UNIPOLAR ENDOCARDIAL LEAD- Cook Pacemaker Corp. | DTB |
| Aug 12, 1983 | K832245 | UNIPOLAR-E ENDOCARDIAL TINED LEAD Cook Pacemaker Corp. | DTB |
| Aug 8, 1983 | K832052 | MODEL 327T UNIPOLAR CARDIAC PULSE GEN Cook Pacemaker Corp. | DXY |
| Oct 15, 1982 | K822904 | MODEL 325D UNIPOLAR CARDIAC PULSE GEN Cook Pacemaker Corp. | DXY |
| Oct 4, 1982 | K822652 | JAIN INSULATING BOOT MODEL 225B Cook Pacemaker Corp. | DXY |
| May 7, 1982 | K821147 | COOK #326T PROGRAM/TELEMETRY BIPOLAR Cook Pacemaker Corp. | DXY |
| Nov 5, 1981 | K812832 | MODEL 325C UNIPOLAR CARDIAC PULSE GEN. Cook Pacemaker Corp. | DXY |
| Oct 29, 1981 | K812358 | MODEL 325T PROGRAMMABLE PULSE GENERATOR Cook Pacemaker Corp. | DXY |
| Aug 3, 1981 | K811879 | MODEL A UNIPOLAR ENDOCARDIAL LEAD Cook Pacemaker Corp. | DTB |
| Aug 3, 1981 | K811878 | MODEL B BIPOLAR ENDOCARDIAL LEAD Cook Pacemaker Corp. | DTB |
| Aug 3, 1981 | K811877 | MODEL C UNIPOLAR ENDOCARDIAL LEAD Cook Pacemaker Corp. | DTB |
| Aug 3, 1981 | K811876 | MODEL D BIPOLAR ENDOCARDIAL LEAD Cook Pacemaker Corp. | DTB |
| Jun 16, 1981 | K810885 | #326 PROGRAMMABLE CARD. PULSE GENERATOR Cook Pacemaker Corp. | DXY |
| Jun 16, 1981 | K810884 | #325 PROGRAMMABLE CARD. PULSE GENERATOR Cook Pacemaker Corp. | DXY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||