Cleared Traditional

K851418 - OMNI-ATRICOR MODEL 308A

K851418 is an FDA 510(k) clearance for OMNI-ATRICOR MODEL 308A, 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 63-day FDA review.

K851418 · Cordis Corp. · Cardiovascular device
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Jun 1985
Decision
63d
Days
Class 3
Risk

K851418 is an FDA 510(k) clearance for the OMNI-ATRICOR MODEL 308A. 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 June 11, 1985 after a review of 63 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 Cordis Corp. devices

FDA 510(k) Submission Details - K851418

510(k) Number K851418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1985
Decision Date June 11, 1985
Days to Decision 63 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
62d faster than avg
Panel avg: 125d · This submission: 63d
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 K851418.
CORDIS MULTICOR S 330A & 331A CARDIAC PACEMAKERS
K844360 · Cordis Corp. · Jun 1985
STANICOR GAMMA 333B/334A
K851416 · Cordis Corp. · Jun 1985
MULTICOR GAMMA MODELS 336/337
K851417 · Cordis Corp. · Jun 1985
MULTICOR GAMMA 402 SERIES PACER
K851419 · Cordis Corp. · Jun 1985
COOK PACEMAKER CORP. 332T BIPOLAR CARDIAC PULSE GE
K851699 · Cook Pacemaker Corp. · May 1985
PROGRAMALITH III MODEL 249 PULSE GENERATOR
K851861 · Pacesetter Systems · May 1985