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 14, 1995 | K944956 | UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491 The Heart Valve Div. Medtronic Cardiovascular Surg | LDF |
| Feb 24, 1995 | K934787 | SILICORE SEMI-FLOATER Electro-Catheter Corp. | LDF |
| Jan 28, 1994 | K930069 | BIPOLAR BALLOON PACING CATHETER BY J-LLOYD J-Lloyd Medical, Inc. | LDF |
| Oct 21, 1993 | K924388 | ANGEMED MODEL 4000 QC BIPOLAR TEMP PACING LEAD Angemed, Inc. | LDF |
| Aug 25, 1993 | K924390 | ANGEMED 5000 LEAD ADAPTER Angemed, Inc. | LDF |
| Nov 23, 1992 | K922269 | UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE, 6493 The Heart Valve Div. Medtronic Cardiovascular Surg | LDF |
| Nov 23, 1992 | K922268 | UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD MOD. 6491 Medtronic Vascular | LDF |
| Nov 23, 1992 | K922182 | UNIPOLAR ATRIAL TEMPORARY PACING LEAD, MODEL 6492 Medtronic Vascular | LDF |
| Oct 19, 1992 | K923407 | MEDTRONIC MODELS 5455L AND 5455SL SURGICAL CABLES Medtronic Vascular | LDF |
| Jan 27, 1992 | K914185 | PACEL(TM) FLOW DIRECTED PACING CATHETER Daig Corp. | LDF |
| Dec 27, 1991 | K913521 | XEMEX TEMPORARY PACING CATHETER A MODIFIED Zeon Medical Corp. | LDF |
| May 16, 1991 | K904868 | XEMEX TEMPORARY PACING CATHETER A Zeon Medical Corp. | LDF |
| Oct 16, 1990 | K902342 | UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, #6491 Medtronic Vascular | LDF |
| Apr 19, 1990 | K900982 | E-CLIP Joel Cohen & Esther R. Cohen | LDF |
| Dec 7, 1989 | K895789 | UNIPOLAR TEMP. MYOCARDIAL HEART WIRE, MODEL 6490 Medtronic Vascular | LDF |
| Aug 25, 1989 | K890988 | MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE Pace Medical | LDF |
| Jun 20, 1989 | K890794 | DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER Daig Corp. | LDF |
| Mar 22, 1989 | K884866 | TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1 Oscor Medical Corp. | LDF |
| Sep 6, 1988 | K882330 | BARD BAIM-TURI BALLOON DIAGNOSTIC PACING CATHETER C.R. Bard, Inc. | LDF |
| Jul 12, 1988 | K882045 | HIGH TORQUE TEMPORARY PERVENOUS LEAD W/DEPTH MARK Cordis Leads, Inc. | LDF |
| May 19, 1988 | K881356 | EXTERNAL PACEMAKER WIRE DRESSING CHANGE Neal & Assoc., Inc. | LDF |
| Feb 12, 1988 | K875059 | DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODE Daig Corp. | LDF |
| Dec 23, 1987 | K874310 | WIRE DRESSING Slocum and Neal, Inc. | LDF |
| Dec 3, 1987 | K872972 | TEMPORARY PACEMAKER ELECTRODE Oscor Medical Corp. | LDF |
| Nov 3, 1987 | K873728 | DEKNATEL TEMPORARY CARDIAC PACING WIRE Deknatel, Inc. | LDF |
| Oct 7, 1987 | K873474 | SUTURELESS TEMPORARY EPICARDIAL PACING LEAD Symbion, Inc. | LDF |
| Oct 2, 1987 | K873716 | ADULT WALKING HEEL PRODUCT NO. 4183-130 Martin Medical | LDF |
| Sep 25, 1987 | K862970 | TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500 Medtronic Vascular | LDF |
| Mar 6, 1987 | K864507 | V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MODEL SP5540 Spectramed, Inc. | LDF |
| Jun 27, 1986 | K861403 | TB SERIES BIPOLAR PACING LEADS Oscor Medical Corp. | LDF |
| May 5, 1986 | K861409 | SYNCARE TEMPORARY CARDIAC PACING WIRE Gyneco, Inc. | LDF |
| Feb 26, 1986 | K855139 | FLEXON TEMPORARY CARDIAC CONDUCTIVE MULTIFILAMENT Davis & Geck, Inc. | LDF |
| Oct 11, 1985 | K853818 | MEDTRONIC MODEL 6405 Medtronic Vascular | LDF |
| Sep 16, 1985 | K852797 | HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODE Mansfield Scientific, Inc. | LDF |
| Sep 16, 1985 | K852513 | 115-GK BARD CARE TRANSLU VENTRICULAR PACING LEAD C.R. Bard, Inc. | LDF |
| Sep 16, 1985 | K851913 | CORDIS HIGH-TORQUE TEMP. PERVENOUS LEAD W/DEPTH MA Cordis Corp. | LDF |
| Aug 29, 1985 | K851845 | NUMED TEMP. STYLET PACING PAROBE 1318694 NuMED, Inc. | LDF |
| Apr 19, 1985 | K851246 | NUMED BALLOON PACING CATHETER NuMED, Inc. | LDF |
| Apr 10, 1985 | K850622 | OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR Oscor Medical Corp. | LDF |
| Mar 27, 1985 | K850324 | ELECATH OPEN TIP BIPOLAR PACING CATHETER Electro-Catheter Corp. | LDF |
| Jan 14, 1985 | K843290 | NUMED BALLOON PACING CATHETER NuMED, Inc. | LDF |
| Dec 27, 1984 | K844003 | ELECATH VENTRICULAR PACING WEDGE PRESSURE CATH Electro-Catheter Corp. | LDF |
| Oct 18, 1984 | K841802 | ELECTRODE CATHETER, ORTHOGONAL TYPE Webster Laboratories, Inc. | LDF |
| Sep 4, 1984 | K843141 | CRITIKON HEPARIN-COATED CARDIOVASCULAR Critikon Company, LLC | LDF |
| Apr 24, 1984 | K834416 | LUMELEC ELECTRODE CATHETER Cordis Corp. | LDF |
| Feb 4, 1984 | K840109 | ELECATH HEPARIN COATED TEMP. PACING Electro-Catheter Corp. | LDF |
| Oct 20, 1983 | K831804 | MULTIPOLAR TEMPORARY CARDIAC Oscor, Inc. | LDF |
| Oct 20, 1983 | K831695 | TEMP. CARDIAC PACING WIRE TME 60/61/65 Oscor, Inc. | LDF |
| Oct 19, 1983 | K832850 | ELECATH PACEWEDGE DUAL PRESS. BIPOLAR Electro-Catheter Corp. | LDF |
| Oct 19, 1983 | K832561 | EPCOR MULTIELECTRODE TEMP. PERVENOUS Cordis Corp. | LDF |
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