Cleared Traditional

K780066 - CARDIAC PACER

K780066 is an FDA 510(k) clearance for CARDIAC PACER, 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 18-day FDA review.

K780066 · Cordis Corp. · Cardiovascular device
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Jan 1978
Decision
18d
Days
Class 3
Risk

K780066 is an FDA 510(k) clearance for the CARDIAC PACER, MODEL 208. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Cordis Corp. (Mchenry, US). The FDA issued a Cleared decision on January 30, 1978 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 Cordis Corp. devices

FDA 510(k) Submission Details - K780066

510(k) Number K780066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1978
Decision Date January 30, 1978
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 353
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K780066.
PULSE GENERATOR, BIPOLAR, PROGRAMMABLE
K772239 · Cardiac Pacemakers, Inc. · Jan 1978
PULSE GENERATOR, UNIPOLAR, DEMAND
K772240 · Cardiac Pacemakers, Inc. · Jan 1978
PULSE GENERATOR, BIPOLAR, DEMAND
K772241 · Cardiac Pacemakers, Inc. · Jan 1978
PULSE GENERATORS, MODELS 5972/5973
K780061 · Medtronic Vascular · Jan 1978
PULSE GENERATORS
K772357 · Medtronic Vascular · Jan 1978
XYREL-RA MODELS 5994/5995
K771770 · Medtronic Vascular · Jan 1978