Company ยท US
Pace Medical
FDA 510(k) clearances and medical device recalls filed under this name, 1987 to 2001. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DTE | Pulse-Generator, Pacemaker, External | 9 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 2 |
| DTB | Permanent Pacemaker Electrode | 2 |
| DXY | Implantable Pacemaker Pulse-Generator | 2 |
| DTC | Analyzer, Pacemaker Generator Function | 1 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 1 |
| DYB | Introducer, Catheter | 1 |
| LDF | Electrode, Pacemaker, Temporary | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 12, 2001 | K011980 | ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825 Pace Medical | DTE |
| Sep 4, 2001 | K012392 | DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260 Pace Medical | DSA |
| Oct 18, 2000 | K002204 | PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V Pace Medical | DTE |
| Oct 10, 2000 | K002497 | MODEL 4810 ANALYZER OUTPUT ADAPTER Pace Medical | DTC |
| Oct 10, 2000 | K002496 | MODEL 4815 ADAPTER Pace Medical | DTN |
| Jun 27, 2000 | K001180 | TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528 Pace Medical | DTE |
| Sep 27, 1994 | K925143 | MODEL 4800 ACCUPACE PACING SYSTEM ANALYER Pace Medical | DTE |
| Aug 31, 1993 | K931662 | LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES Pace Medical | DYB |
| Dec 23, 1992 | K922899 | MODEL 4280 SURGICAL EXTENSION CABLE Pace Medical | DSA |
| Nov 19, 1991 | K913805 | MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER Pace Medical | DTE |
| Aug 22, 1991 | K913134 | MODEL 4220 Pace Medical | DXY |
| Jul 26, 1991 | K912545 | MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE Pace Medical | DXY |
| Jul 19, 1990 | K902679 | MODELS 4201, 4231 & 4235 EXTENSION CABLES Pace Medical | DTE |
| Jan 24, 1990 | K896352 | MODEL EC4542G MINIATURE Pace Medical | DTE |
| Aug 25, 1989 | K890988 | MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE Pace Medical | LDF |
| Jan 19, 1988 | K874743 | PACING LEADS MODEL 3262VU/VB, 3362VU/VB, 3380/3390 Pace Medical | DTB |
| Jun 10, 1987 | K871915 | MINIATURE TEMP. CARDIAC PACEMAKERS EC4542 & EC4543 Pace Medical | DTE |
| Mar 3, 1987 | K870323 | MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER Pace Medical | DTE |
| Jan 6, 1987 | K864153 | PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL 3290 Pace Medical | DTB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||