Company ยท US
Electro-Catheter Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1995. Name variants (Inc, Corp, punctuation) are merged.
35510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LDF | Electrode, Pacemaker, Temporary | 7 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 5 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 4 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 3 |
| DQO | Catheter, Intravascular, Diagnostic | 2 |
| DQX | Wire, Guide, Catheter | 2 |
| DYG | Catheter, Flow Directed | 2 |
| BWF | Spirometer, Therapeutic (Incentive) | 1 |
| DQR | Cannula, Catheter | 1 |
| DTB | Permanent Pacemaker Electrode | 1 |
| DXE | Catheter, Embolectomy | 1 |
| DYB | Introducer, Catheter | 1 |
| GBA | Catheter, Balloon Type | 1 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 1 |
| KNN | Components, Wheelchair | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 |
| KYG | Device, Irrigation, Ocular Surgery | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 27, 1995 | K934785 | MULTIPACE Electro-Catheter Corp. | LDF |
| Apr 19, 1995 | K943257 | TIP DEFLECTOR (GENESIS) Electro-Catheter Corp. | DRF |
| Apr 19, 1995 | K933451 | OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATION Electro-Catheter Corp. | DRF |
| Apr 19, 1995 | K933450 | CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATION Electro-Catheter Corp. | DRF |
| Feb 24, 1995 | K934787 | SILICORE SEMI-FLOATER Electro-Catheter Corp. | LDF |
| Apr 29, 1988 | K874154 | ELECATH(R) TRANSESOPHAGEAL PACING CATHETER Electro-Catheter Corp. | KNT |
| Feb 10, 1986 | K854511 | ELECATH PERCUTANEOUS LEFT ATRIAL CANNULATION SET Electro-Catheter Corp. | DQX |
| Jan 15, 1986 | K854975 | ELECATH PULSATILE PERFUSION PUMP Electro-Catheter Corp. | KFM |
| Apr 10, 1985 | K850065 | ELECATH TORKFLOAT PACING PROBE Electro-Catheter Corp. | DTB |
| Mar 27, 1985 | K850324 | ELECATH OPEN TIP BIPOLAR PACING CATHETER Electro-Catheter Corp. | LDF |
| Mar 6, 1985 | K844682 | ELECATH CARDIAC OUTPUT COMPUTER Electro-Catheter Corp. | DXG |
| Jan 2, 1985 | K844805 | ELECATH GALLAGHER MAPPING CATHETER Electro-Catheter Corp. | DRF |
| Dec 27, 1984 | K844003 | ELECATH VENTRICULAR PACING WEDGE PRESSURE CATH Electro-Catheter Corp. | LDF |
| Nov 20, 1984 | K844022 | ELECATH VENTRICULAR PACING THERMAL DILUTION CATH Electro-Catheter Corp. | DXG |
| Aug 27, 1984 | K842831 | BAIM CORONARY SINUS FLOW CALCULATOR Electro-Catheter Corp. | DXG |
| Aug 27, 1984 | K842369 | ELECATH INFANT ARTERIAL & VENOUS CANNU Electro-Catheter Corp. | BWF |
| Jun 5, 1984 | K841615 | ELECATH HEPARIN-COATED CATHETERS Electro-Catheter Corp. | DQO |
| Feb 4, 1984 | K840109 | ELECATH HEPARIN COATED TEMP. PACING Electro-Catheter Corp. | LDF |
| Oct 19, 1983 | K832850 | ELECATH PACEWEDGE DUAL PRESS. BIPOLAR Electro-Catheter Corp. | LDF |
| Oct 4, 1983 | K832787 | ELECATH HEPARIN COATED THERMAL DILUTION Electro-Catheter Corp. | KYG |
| Aug 12, 1983 | K831945 | ELECATH BALTHERM TLC THERMAL DILUTION Electro-Catheter Corp. | DYG |
| May 28, 1982 | K821488 | ELECATH PORTAL VEIN/BILIARY DRAIN ASSM Electro-Catheter Corp. | KNN |
| Jun 12, 1981 | K811414 | BAIM CORONARY SINUS FLOW ANALYZER Electro-Catheter Corp. | DXG |
| Mar 11, 1981 | K810360 | BAIM TM CORONARY SINUS FLOW THERMAL Electro-Catheter Corp. | DQO |
| Mar 4, 1981 | K810312 | ELECATH DUAL MODE TRANSTHORACIC PACING Electro-Catheter Corp. | LDF |
| Dec 22, 1980 | K803002 | ELECATH FLUID-DRAIN ASSEMBLY Electro-Catheter Corp. | DQR |
| Jun 11, 1979 | K790444 | ELECATH MULTI-PURPOSE ARTERIAL SURGER Electro-Catheter Corp. | GBA |
| Apr 10, 1978 | K780493 | ELECATH PLASTIC JACKETED GUIDEWIRE Electro-Catheter Corp. | DQX |
| Nov 15, 1977 | K772059 | CATHETER, PACING/MONITORING Electro-Catheter Corp. | DYG |
| Mar 16, 1977 | K770427 | CATHETER INTRODUCER KIT Electro-Catheter Corp. | DYB |
| Feb 28, 1977 | K770341 | TEMP. PROBE, & ELECTRONIC THERMOMETER Electro-Catheter Corp. | DRF |
| Jan 14, 1977 | K770018 | PACING KIT, SEMI-FLOATING Electro-Catheter Corp. | DTR |
| Jan 14, 1977 | K770017 | PACING KIT, TRANSMYOCARDIAL Electro-Catheter Corp. | DTR |
| Jan 14, 1977 | K770016 | PACING KIT, ELECATH TRANSTHORACIC Electro-Catheter Corp. | DTR |
| Dec 13, 1976 | K761031 | ELECATH ARTERIAL EMBOLECTOMY CATHETER Electro-Catheter Corp. | DXE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||