Cleared Traditional

EXTERNAL SILASTIC BOOT FOR CARDIAC PULSE (K801806) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K801806 · Arco Medical Products Co. · Cardiovascular device
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Sep 1980
Decision
41d
Days
Class 3
Risk

K801806 is an FDA 510(k) clearance for the EXTERNAL SILASTIC BOOT FOR CARDIAC PULSE. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Arco Medical Products Co. (Mchenry, US). The FDA issued a Cleared decision on September 9, 1980 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3610 - 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: High-complexity regulatory submission. High regulatory complexity 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 Arco Medical Products Co. devices

Submission Details

510(k) Number K801806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1980
Decision Date September 09, 1980
Days to Decision 41 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 125d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DXY Implantable Pacemaker Pulse-generator
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3610
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - DXY Implantable Pacemaker Pulse-generator

All 135
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K801806.
MULTI-PROGRAMMABLE PACEMAKER & PROGRMR.
K801584 · Medtronic Vascular · Feb 1981
CYBERLITH PROGRAMMER
K801338 · Intermedics, Inc. · Jan 1981
MEDTRONIC MODEL 2409
K800226 · Medtronic Vascular · Sep 1980
INSULATING SHEATH
K801910 · Cordis Corp. · Sep 1980
BATTERY FOR #229-01 PULSE GENERATOR
K802040 · Intermedics, Inc. · Sep 1980
INTERMEDICS THIN LITH IV SERIES UNIPOLAR
K801450 · Intermedics, Inc. · Aug 1980