Cleared Traditional

K844003 - ELECATH VENTRICULAR PACING WEDGE PRESSURE CATH

K844003 is an FDA 510(k) clearance for ELECATH VENTRICULAR PACING WEDGE PRESSU..., manufactured by Electro-Catheter Corp.. The device is a Class 2 Cardiovascular device with product code LDF cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K844003 · Electro-Catheter Corp. · Cardiovascular device
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Dec 1984
Decision
76d
Days
Class 2
Risk

K844003 is an FDA 510(k) clearance for the ELECATH VENTRICULAR PACING WEDGE PRESSURE CATH. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Electro-Catheter Corp. (Rahway, US). The FDA issued a Cleared decision on December 27, 1984 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Electro-Catheter Corp. devices

FDA 510(k) Submission Details - K844003

510(k) Number K844003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1984
Decision Date December 27, 1984
Days to Decision 76 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 125d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDF Device Classification - Class 2, Special Controls

Product Code LDF Electrode, Pacemaker, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3680
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - LDF Electrode, Pacemaker, Temporary

All 89
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K844003.
OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR
K850622 · Oscor Medical Corp. · Apr 1985
ELECATH OPEN TIP BIPOLAR PACING CATHETER
K850324 · Electro-Catheter Corp. · Mar 1985
NUMED BALLOON PACING CATHETER
K843290 · NuMED, Inc. · Jan 1985
CRITIKON HEPARIN-COATED CARDIOVASCULAR
K843141 · Critikon Company, LLC · Sep 1984
LUMELEC ELECTRODE CATHETER
K834416 · Cordis Corp. · Apr 1984
ELECATH HEPARIN COATED TEMP. PACING
K840109 · Electro-Catheter Corp. · Feb 1984