Cleared Traditional

K852253 - 329 CORDIS ENCOR PREVENOUS ARTRIAL & VE...

K852253 is an FDA 510(k) clearance for 329 CORDIS ENCOR PREVENOUS ARTRIAL & VE..., manufactured by Cordis Corp.. The device is a Class 2 Cardiovascular device with product code DTD cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K852253 · Cordis Corp. · Cardiovascular device
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Jul 1985
Decision
66d
Days
Class 2
Risk

K852253 is an FDA 510(k) clearance for the 329 CORDIS ENCOR PREVENOUS ARTRIAL & VENTRICULAR. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Cordis Corp. (Miami, US). The FDA issued a Cleared decision on July 29, 1985 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3620 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cordis Corp. devices

FDA 510(k) Submission Details - K852253

510(k) Number K852253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1985
Decision Date July 29, 1985
Days to Decision 66 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
59d faster than avg
Panel avg: 125d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTD Device Classification - Class 2, Special Controls

Product Code DTD Pacemaker Lead Adaptor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DTD Pacemaker Lead Adaptor

All 86
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K852253.
MEDTRONIC MODEL 4016 BIPOLAR ENDOCARDIAL SCREW-IN
K850968 · Medtronic Vascular · Aug 1985
CCS MODEL AV-106 IMPLANTABLE A-V DATA LEAD
K851897 · Cardiac Control Systems, Inc. · Aug 1985
MEDTRONIC MODEL 5561
K852356 · Medtronic Vascular · Aug 1985
MODEL 483-06 POLYFLEX IMPLANTABLE PACING LEAD
K851457 · Intermedics, Inc. · Jul 1985
MODEL 493-04 POLYFLEX R IMPLANTABLE PACING LEAD
K851458 · Intermedics, Inc. · Jul 1985
MEDTRONIC 5064
K851890 · Medtronic Vascular · Jun 1985