Cleared Traditional

K801799 - ATRIAL/VENTRICULAR SEQENTIAL #080-20000

K801799 is the FDA 510(k) clearance for ATRIAL/VENTRICULAR SEQENTIAL #080-20000 by Medical Testing System, Inc.. It is a Class 2 Cardiovascular device (product code LDF) cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K801799 · Medical Testing System, Inc. · Cardiovascular device
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Jan 1981
Decision
157d
Days
Class 2
Risk

K801799 is an FDA 510(k) clearance for the ATRIAL/VENTRICULAR SEQENTIAL #080-20000. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Medical Testing System, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 2, 1981 after a review of 157 days - an extended review 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: 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 Medical Testing System, Inc. devices

Submission Details

510(k) Number K801799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1980
Decision Date January 02, 1981
Days to Decision 157 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 125d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 82
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K801799.
ELECATH DUAL MODE TRANSTHORACIC PACING
K810312 · Electro-Catheter Corp. · Mar 1981
CORDIS TEMPORATY CURVED ATRIAL LEAD
K810041 · Cordis Corp. · Feb 1981
SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH.
K803058 · American Edwards Laboratories · Jan 1981
USCI BIPOLAR BALLON PACING ELECTRODE
K800298 · C.R. Bard, Inc. · Apr 1980
SWAN-GANZ FLOW-DIRECTED CATHETER
K791183 · Edwards Lifesciences, LLC · Jul 1979
TEMPORARY CARDIAC PACING WIRE
K781002 · Ethicon, Inc. · Dec 1978