Electro-Catheter Corp.
Mchenry, IL, US
Electro-Catheter Corp. appears in FDA device records in Mchenry, IL. FDA records list 35 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 35
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 35 510(k) clearances for Electro-Catheter Corp. between 1976 and 1995. The busiest year on record is 1977, with 6. The most recent is 1995, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 6 |
| 1978 | 1 |
| 1979 | 1 |
| 1980 | 1 |
| 1981 | 3 |
| 1982 | 1 |
| 1983 | 3 |
| 1984 | 6 |
| 1985 | 4 |
| 1986 | 2 |
| 1988 | 1 |
| 1995 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K934785 | MULTIPACE | LDF | Substantially Equivalent | |
| K943257 | TIP DEFLECTOR (GENESIS) | DRF | Substantially Equivalent | |
| K933451 | OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATION | DRF | Substantially Equivalent | |
| K933450 | CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATION | DRF | Substantially Equivalent | |
| K934787 | SILICORE SEMI-FLOATER | LDF | Substantially Equivalent | |
| K874154 | ELECATH(R) TRANSESOPHAGEAL PACING CATHETER | KNT | Substantially Equivalent | |
| K854511 | ELECATH PERCUTANEOUS LEFT ATRIAL CANNULATION SET | DQX | Substantially Equivalent | |
| K854975 | ELECATH PULSATILE PERFUSION PUMP | KFM | Substantially Equivalent | |
| K850065 | ELECATH TORKFLOAT PACING PROBE | DTB | Substantially Equivalent | |
| K850324 | ELECATH OPEN TIP BIPOLAR PACING CATHETER | LDF | Substantially Equivalent | |
| K844682 | ELECATH CARDIAC OUTPUT COMPUTER | DXG | Substantially Equivalent | |
| K844805 | ELECATH GALLAGHER MAPPING CATHETER | DRF | Substantially Equivalent | |
| K844003 | ELECATH VENTRICULAR PACING WEDGE PRESSURE CATH | LDF | Substantially Equivalent | |
| K844022 | ELECATH VENTRICULAR PACING THERMAL DILUTION CATH | DXG | Substantially Equivalent | |
| K842831 | BAIM CORONARY SINUS FLOW CALCULATOR | DXG | Substantially Equivalent | |
| K842369 | ELECATH INFANT ARTERIAL & VENOUS CANNU | BWF | Substantially Equivalent | |
| K841615 | ELECATH HEPARIN-COATED CATHETERS | DQO | Substantially Equivalent | |
| K840109 | ELECATH HEPARIN COATED TEMP. PACING | LDF | Substantially Equivalent | |
| K832850 | ELECATH PACEWEDGE DUAL PRESS. BIPOLAR | LDF | Substantially Equivalent | |
| K832787 | ELECATH HEPARIN COATED THERMAL DILUTION | KYG | Substantially Equivalent | |
| K831945 | ELECATH BALTHERM TLC THERMAL DILUTION | DYG | Substantially Equivalent | |
| K821488 | ELECATH PORTAL VEIN/BILIARY DRAIN ASSM | KNN | Substantially Equivalent | |
| K811414 | BAIM CORONARY SINUS FLOW ANALYZER | DXG | Substantially Equivalent | |
| K810360 | BAIM TM CORONARY SINUS FLOW THERMAL | DQO | Substantially Equivalent | |
| K810312 | ELECATH DUAL MODE TRANSTHORACIC PACING | LDF | Substantially Equivalent | |
| K803002 | ELECATH FLUID-DRAIN ASSEMBLY | DQR | Substantially Equivalent | |
| K790444 | ELECATH MULTI-PURPOSE ARTERIAL SURGER | GBA | Substantially Equivalent | |
| K780493 | ELECATH PLASTIC JACKETED GUIDEWIRE | DQX | Substantially Equivalent | |
| K772059 | CATHETER, PACING/MONITORING | DYG | Substantially Equivalent | |
| K770427 | CATHETER INTRODUCER KIT | DYB | Substantially Equivalent | |
| K770341 | TEMP. PROBE, & ELECTRONIC THERMOMETER | DRF | Substantially Equivalent | |
| K770018 | PACING KIT, SEMI-FLOATING | DTR | Substantially Equivalent | |
| K770017 | PACING KIT, TRANSMYOCARDIAL | DTR | Substantially Equivalent | |
| K770016 | PACING KIT, ELECATH TRANSTHORACIC | DTR | Substantially Equivalent | |
| K761031 | ELECATH ARTERIAL EMBOLECTOMY CATHETER | DXE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DQRCannula, Catheter
- GBACatheter, Balloon Type
- DRFCatheter, Electrode Recording, Or Probe, Electrode Recording
- DXECatheter, Embolectomy
- DYGCatheter, Flow Directed
- DQOCatheter, Intravascular, Diagnostic
- KNNComponents, Wheelchair
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- KYGDevice, Irrigation, Ocular Surgery
- LDFElectrode, Pacemaker, Temporary
- DTRHeat-Exchanger, Cardiopulmonary Bypass
- DYBIntroducer, Catheter
- DTBPermanent Pacemaker Electrode
- KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- BWFSpirometer, Therapeutic (Incentive)
- KNTTubes, Gastrointestinal (And Accessories)
- DQXWire, Guide, Catheter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain