Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Electro-Catheter Corp. — Predicate Candidate Screening

35 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

38 daysmedian FDA review time

507 days90th percentile

35clearances measured

K-number	Device	Applicant	Decided	Review days
K934785	MULTIPACE	Electro-Catheter Corp.	1995-07-27	660
K933451	OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATION	Electro-Catheter Corp.	1995-04-19	646
K943257	TIP DEFLECTOR (GENESIS)	Electro-Catheter Corp.	1995-04-19	287
K933450	CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATION	Electro-Catheter Corp.	1995-04-19	646
K934787	SILICORE SEMI-FLOATER	Electro-Catheter Corp.	1995-02-24	507
K874154	ELECATH(R) TRANSESOPHAGEAL PACING CATHETER	Electro-Catheter Corp.	1988-04-29	199
K854511	ELECATH PERCUTANEOUS LEFT ATRIAL CANNULATION SET	Electro-Catheter Corp.	1986-02-10	90
K854975	ELECATH PULSATILE PERFUSION PUMP	Electro-Catheter Corp.	1986-01-15	34
K850065	ELECATH TORKFLOAT PACING PROBE	Electro-Catheter Corp.	1985-04-10	92
K850324	ELECATH OPEN TIP BIPOLAR PACING CATHETER	Electro-Catheter Corp.	1985-03-27	58
K844682	ELECATH CARDIAC OUTPUT COMPUTER	Electro-Catheter Corp.	1985-03-06	96
K844805	ELECATH GALLAGHER MAPPING CATHETER	Electro-Catheter Corp.	1985-01-02	22
K844003	ELECATH VENTRICULAR PACING WEDGE PRESSURE CATH	Electro-Catheter Corp.	1984-12-27	76
K844022	ELECATH VENTRICULAR PACING THERMAL DILUTION CATH	Electro-Catheter Corp.	1984-11-20	36
K842369	ELECATH INFANT ARTERIAL & VENOUS CANNU	Electro-Catheter Corp.	1984-08-27	73
K842831	BAIM CORONARY SINUS FLOW CALCULATOR	Electro-Catheter Corp.	1984-08-27	38
K841615	ELECATH HEPARIN-COATED CATHETERS	Electro-Catheter Corp.	1984-06-05	64
K840109	ELECATH HEPARIN COATED TEMP. PACING	Electro-Catheter Corp.	1984-02-04	25
K832850	ELECATH PACEWEDGE DUAL PRESS. BIPOLAR	Electro-Catheter Corp.	1983-10-19	58
K832787	ELECATH HEPARIN COATED THERMAL DILUTION	Electro-Catheter Corp.	1983-10-04	49
K831945	ELECATH BALTHERM TLC THERMAL DILUTION	Electro-Catheter Corp.	1983-08-12	57
K821488	ELECATH PORTAL VEIN/BILIARY DRAIN ASSM	Electro-Catheter Corp.	1982-05-28	10
K811414	BAIM CORONARY SINUS FLOW ANALYZER	Electro-Catheter Corp.	1981-06-12	24
K810360	BAIM TM CORONARY SINUS FLOW THERMAL	Electro-Catheter Corp.	1981-03-11	29
K810312	ELECATH DUAL MODE TRANSTHORACIC PACING	Electro-Catheter Corp.	1981-03-04	27
K803002	ELECATH FLUID-DRAIN ASSEMBLY	Electro-Catheter Corp.	1980-12-22	27
K790444	ELECATH MULTI-PURPOSE ARTERIAL SURGER	Electro-Catheter Corp.	1979-06-11	97
K780493	ELECATH PLASTIC JACKETED GUIDEWIRE	Electro-Catheter Corp.	1978-04-10	14
K772059	CATHETER, PACING/MONITORING	Electro-Catheter Corp.	1977-11-15	15
K770427	CATHETER INTRODUCER KIT	Electro-Catheter Corp.	1977-03-16	9
K770341	TEMP. PROBE, & ELECTRONIC THERMOMETER	Electro-Catheter Corp.	1977-02-28	10
K770017	PACING KIT, TRANSMYOCARDIAL	Electro-Catheter Corp.	1977-01-14	10
K770016	PACING KIT, ELECATH TRANSTHORACIC	Electro-Catheter Corp.	1977-01-14	10
K770018	PACING KIT, SEMI-FLOATING	Electro-Catheter Corp.	1977-01-14	10
K761031	ELECATH ARTERIAL EMBOLECTOMY CATHETER	Electro-Catheter Corp.	1976-12-13	28

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda