Cleared Traditional

K926549 - ENDOCATH ELECTROPHYSIOLOGY CATHETER

K926549 is an FDA 510(k) clearance for ENDOCATH ELECTROPHYSIOLOGY CATHETER, manufactured by Endo-Therapeutics, Inc.. The device is a Class 2 Cardiovascular device with product code DRF cleared through the Traditional 510(k) pathway after a 340-day FDA review.

K926549 · Endo-Therapeutics, Inc. · Cardiovascular device
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Dec 1993
Decision
340d
Days
Class 2
Risk

K926549 is an FDA 510(k) clearance for the ENDOCATH ELECTROPHYSIOLOGY CATHETER. Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by Endo-Therapeutics, Inc. (St. Paul, US). The FDA issued a Cleared decision on December 6, 1993 after a review of 340 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Endo-Therapeutics, Inc. devices

FDA 510(k) Submission Details - K926549

510(k) Number K926549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1992
Decision Date December 06, 1993
Days to Decision 340 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
215d slower than avg
Panel avg: 125d · This submission: 340d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRF Device Classification - Class 2, Special Controls

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 99
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K926549.
OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATION
K933451 · Electro-Catheter Corp. · Apr 1995
TIP DEFLECTOR (GENESIS)
K943257 · Electro-Catheter Corp. · Apr 1995
DAIG DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER
K942379 · Daig Corp. · Dec 1994
EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELEC
K924163 · Boston Scientific Corp · Sep 1993
ARROW QUADPOLAR MAPPING/PACING CATHETER
K911065 · Arrow Intl., Inc. · Jun 1992
DAIG ELECTROPHYSIOLOGY CATHETER W/INFUSION LUMEN
K914278 · Daig Corp. · Mar 1992