Cleared Traditional

K903136 - ARZO TAPCATH ESOPHAGEAL RECORDING CATHETER

K903136 is the FDA 510(k) clearance for ARZO TAPCATH ESOPHAGEAL RECORDING CATHETER by Arzco Medical Electronics, Inc.. It is a Class 2 Cardiovascular device (product code DRF) cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K903136 · Arzco Medical Electronics, Inc. · Cardiovascular device
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Jan 1991
Decision
185d
Days
Class 2
Risk

K903136 is an FDA 510(k) clearance for the ARZO TAPCATH ESOPHAGEAL RECORDING CATHETER. Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by Arzco Medical Electronics, Inc. (Vernon Hills, US). The FDA issued a Cleared decision on January 18, 1991 after a review of 185 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Arzco Medical Electronics, Inc. devices

Submission Details

510(k) Number K903136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1990
Decision Date January 18, 1991
Days to Decision 185 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 125d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1220
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 - DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

All 87
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K903136.
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MODIFIED EPICARDIAL ARRAY
K902228 · C.R. Bard, Inc. · Jul 1990
BARD(R) TIP DEFLECTING ELECTRODE CATHETER
K891908 · C.R. Bard, Inc. · Jun 1989
ELECTROPHYSIOLOGY ELECTRODE CATH. W/SILVER/SILVER
K881966 · C.R. Bard, Inc. · Oct 1988