Cleared Traditional

K860466 - MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN.

K860466 is an FDA 510(k) clearance for MODEL 329D, manufactured by Cook Pacemaker Corp.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K860466 · Cook Pacemaker Corp. · Cardiovascular device
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Feb 1986
Decision
18d
Days
Class 3
Risk

K860466 is an FDA 510(k) clearance for the MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN.. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Cook Pacemaker Corp. (Leechburg, US). The FDA issued a Cleared decision on February 24, 1986 after a review of 18 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 Cook Pacemaker Corp. devices

FDA 510(k) Submission Details - K860466

510(k) Number K860466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1986
Decision Date February 24, 1986
Days to Decision 18 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
107d faster than avg
Panel avg: 125d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

DXY Device Classification - Class 3, Premarket Approval

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 393
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K860466.
CCS IMPLANTABLE MAESTRO SERIES 200 CARDIAC PACEMAK
K853400 · Cardiac Control Systems, Inc. · Feb 1986
CCS IMPLANTABLE MAESTRO 106/206/210 CARDIAC PACEMA
K853471 · Cardiac Control Systems, Inc. · Feb 1986
MODEL 327D, SERIES R UNIPOLAR CARDIAC PULSE GENER.
K860202 · Cook Pacemaker Corp. · Feb 1986
TELEMETRY WAND MODEL
K855171 · Cardiac Pacemakers, Inc. · Jan 1986
IMPLANTABLE PROGRAMMABLE PULSE GENERATOR
K854560 · Telectronics, Inc. · Jan 1986
CORDIS MULTICOR ST, MODEL 350A
K851968 · Cordis Corp. · Jan 1986