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Electro-Catheter Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
35
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K934785MULTIPACEJuly 27, 1995
K933451OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATIONApril 19, 1995
K943257TIP DEFLECTOR (GENESIS)April 19, 1995
K933450CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATIONApril 19, 1995
K934787SILICORE SEMI-FLOATERFebruary 24, 1995
K874154ELECATH(R) TRANSESOPHAGEAL PACING CATHETERApril 29, 1988
K854511ELECATH PERCUTANEOUS LEFT ATRIAL CANNULATION SETFebruary 10, 1986
K854975ELECATH PULSATILE PERFUSION PUMPJanuary 15, 1986
K850065ELECATH TORKFLOAT PACING PROBEApril 10, 1985
K850324ELECATH OPEN TIP BIPOLAR PACING CATHETERMarch 27, 1985
K844682ELECATH CARDIAC OUTPUT COMPUTERMarch 6, 1985
K844805ELECATH GALLAGHER MAPPING CATHETERJanuary 2, 1985
K844003ELECATH VENTRICULAR PACING WEDGE PRESSURE CATHDecember 27, 1984
K844022ELECATH VENTRICULAR PACING THERMAL DILUTION CATHNovember 20, 1984
K842831BAIM CORONARY SINUS FLOW CALCULATORAugust 27, 1984
K842369ELECATH INFANT ARTERIAL & VENOUS CANNUAugust 27, 1984
K841615ELECATH HEPARIN-COATED CATHETERSJune 5, 1984
K840109ELECATH HEPARIN COATED TEMP. PACINGFebruary 4, 1984
K832850ELECATH PACEWEDGE DUAL PRESS. BIPOLAROctober 19, 1983
K832787ELECATH HEPARIN COATED THERMAL DILUTIONOctober 4, 1983