Cleared Traditional

K851968 - CORDIS MULTICOR ST

K851968 is an FDA 510(k) clearance for CORDIS MULTICOR ST, manufactured by Cordis Corp.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K851968 · Cordis Corp. · Cardiovascular device
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Jan 1986
Decision
252d
Days
Class 3
Risk

K851968 is an FDA 510(k) clearance for the CORDIS MULTICOR ST, MODEL 350A. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Cordis Corp. (Miami, US). The FDA issued a Cleared decision on January 14, 1986 after a review of 252 days - an extended review 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 Cordis Corp. devices

FDA 510(k) Submission Details - K851968

510(k) Number K851968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1985
Decision Date January 14, 1986
Days to Decision 252 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
127d slower than avg
Panel avg: 125d · This submission: 252d
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 353
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K851968.
MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN.
K860466 · Cook Pacemaker Corp. · Feb 1986
TELEMETRY WAND MODEL
K855171 · Cardiac Pacemakers, Inc. · Jan 1986
IMPLANTABLE PROGRAMMABLE PULSE GENERATOR
K854560 · Telectronics, Inc. · Jan 1986
PROGRAMALITH III MODELS 238 & 239
K854195 · Pacesetter Systems · Jan 1986
BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY
K854919 · Cook Pacemaker Corp. · Dec 1985
COOK PACEMAKER 332T, SERIES R BIPOLAR CARDIAC PULS
K854132 · Cook Pacemaker Corp. · Dec 1985