Panels › Cardiovascular › Product code LDF · Class 2
Electrode, Pacemaker, Temporary
Regulation 870.3680
1510(k)s in 12 months (130 all time)
1recalls in 12 months (15 all time)
14recalls that name a 510(k)
Top companies in LDF
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Vascular | 21 | 0 |
| C.R. Bard, Inc. | 8 | 0 |
| Electro-Catheter Corp. | 7 | 0 |
| Medtronic | 5 | 1 |
| Oscor, Inc. | 4 | 2 |
| Cordis Corp. | 5 | 0 |
| ETHICON, Inc. | 5 | 0 |
| ARROW INTERNATIONAL, LLC | 0 | 4 |
| Oscor Medical Corp. | 4 | 0 |
| Daig Corp. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 26, 1983 | K831645 | TEMP. BIPOLAR EPICARDIAL LEAD Cordic Corp. | LDF |
| Apr 18, 1983 | K830772 | TEMP. PACING LEAD, BIPOLAR #TH60, 90/110 Oscor, Inc. | LDF |
| Feb 18, 1983 | K830094 | USCI TEMP. ATRIO-VENTRICULAR ELECTRODE C.R. Bard, Inc. | LDF |
| Oct 15, 1982 | K822003 | BALLOON TEMP. PACING CATHETER Ziehm International, Inc. | LDF |
| Oct 15, 1982 | K822002 | BIPOLAR TEMP. PACING CATHETER W/STYLETET Ziehm International, Inc. | LDF |
| Aug 24, 1982 | K822155 | ETHICON TEMPORARY CARDIAC PACING WIRE ETHICON, Inc. | LDF |
| Jul 8, 1982 | K821518 | MYO/CLIP Alto Development Corp. | LDF |
| Jun 2, 1982 | K821333 | ATRIAL J TEMPORARY PACING ELECTRODESS Medics Instrument Corp. | LDF |
| Apr 9, 1982 | K820232 | TRANSTHORACIC TEMP. PACEMAKER #100TPE Trans Pace, Inc. | LDF |
| Mar 26, 1982 | K820003 | CARDIOVASCULAR TEMP. PACEMAKER ELEC Diag Corp. | LDF |
| Mar 15, 1982 | K813521 | TRANSLUMINAL BIPOLAR PACING PROBE American Edwards Laboratories | LDF |
| Dec 10, 1981 | K813138 | ETHICON* TEMP. CARDIAC PACING WIRE ETHICON, Inc. | LDF |
| Nov 16, 1981 | K812725 | MODEL 5867-12 BIPOLAR LOW-PROFILE LEAD Medtronic Vascular | LDF |
| Oct 29, 1981 | K812781 | TEMPORARY PERVENOUS J-ATRIAL LEAD Cordis Corp. | LDF |
| Oct 13, 1981 | K812517 | CARDIAC PACING ELECTRODES Medics Instrument Corp. | LDF |
| Sep 21, 1981 | K812307 | USCI TRANSTHORACIC TEMP. PACING ELECTROD C.R. Bard, Inc. | LDF |
| Jul 20, 1981 | K811318 | TEMPORARY ENDOCARDIAL TRIPOLAR LD. #6880 Medtronic Vascular | LDF |
| Jul 1, 1981 | K803086 | MYOWIRE-ATEMPORARY CARDIAC PACING WIRE Craig & Craig, Inc. | LDF |
| Apr 8, 1981 | K810657 | TEMPTRON #'S 6804/6805 Medtronic Vascular | LDF |
| Apr 8, 1981 | K810643 | UNIVERSAL PACING ELECTRODE KIT Stanco Medical, Inc. | LDF |
| Apr 8, 1981 | K810642 | ATRIAL-VENTRICULAR PACING ELECTRODE KIT Stanco Medical, Inc. | LDF |
| Mar 4, 1981 | K810312 | ELECATH DUAL MODE TRANSTHORACIC PACING Electro-Catheter Corp. | LDF |
| Feb 5, 1981 | K810041 | CORDIS TEMPORATY CURVED ATRIAL LEAD Cordis Corp. | LDF |
| Jan 16, 1981 | K803058 | SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH. American Edwards Laboratories | LDF |
| Jan 2, 1981 | K801799 | ATRIAL/VENTRICULAR SEQENTIAL #080-20000 Medical Testing System, Inc. | LDF |
| Oct 23, 1980 | K802259 | TRANSVENOUS PACEMAKER ELECTRODE KIT Stanco Medical, Inc. | LDF |
| Oct 23, 1980 | K801800 | UNIVERSAL TEMP. PACING ELECT. #080-10000 Medical Testing System, Inc. | LDF |
| Apr 16, 1980 | K800298 | USCI BIPOLAR BALLON PACING ELECTRODE C.R. Bard, Inc. | LDF |
| Jul 12, 1979 | K791183 | SWAN-GANZ FLOW-DIRECTED CATHETER Edwards Lifesciences, LLC | LDF |
| Dec 4, 1978 | K781002 | TEMPORARY CARDIAC PACING WIRE ETHICON, Inc. | LDF |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.