Cleared Traditional

K813521 - TRANSLUMINAL BIPOLAR PACING PROBE

K813521 is the FDA 510(k) clearance for TRANSLUMINAL BIPOLAR PACING PROBE by American Edwards Laboratories. It is a Class 2 Cardiovascular device (product code LDF) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K813521 · American Edwards Laboratories · Cardiovascular device

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Mar 1982

Decision

89d

Days

Class 2

Risk

K813521 is an FDA 510(k) clearance for the TRANSLUMINAL BIPOLAR PACING PROBE. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by American Edwards Laboratories (Walker, US). The FDA issued a Cleared decision on March 15, 1982 after a review of 89 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 American Edwards Laboratories devices

Submission Details

510(k) Number	K813521 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 16, 1981
Decision Date	March 15, 1982
Days to Decision	89 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

36d faster than avg

Panel avg: 125d · This submission: 89d

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 75

Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K813521.

ELECATH PACEWEDGE DUAL PRESS. BIPOLAR

K832850 · Electro-Catheter Corp. · Oct 1983

TEMP. PACING LEAD, BIPOLAR #TH60, 90/110

K830772 · Oscor, Inc. · Apr 1983

USCI TEMP. ATRIO-VENTRICULAR ELECTRODE

K830094 · C.R. Bard, Inc. · Feb 1983

ETHICON* TEMP. CARDIAC PACING WIRE

K813138 · Ethicon, Inc. · Dec 1981

MODEL 5867-12 BIPOLAR LOW-PROFILE LEAD

K812725 · Medtronic Vascular · Nov 1981

TEMPORARY PERVENOUS J-ATRIAL LEAD

K812781 · Cordis Corp. · Oct 1981

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K813521

American Edwards Laboratories

Walker, MI · US

Regulatory profile

89 submissions 88 cleared

99% clearance rate · Active in Cardiovascular

Data Intelligence Layer

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Sourced from FDA 510(k) public files . Updated monthly.

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