Cleared Traditional

K851458 - MODEL 493-04 POLYFLEX R IMPLANTABLE PAC...

K851458 is an FDA 510(k) clearance for MODEL 493-04 POLYFLEX R IMPLANTABLE PAC..., manufactured by Intermedics, Inc.. The device is a Class 2 Cardiovascular device with product code DTD cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K851458 · Intermedics, Inc. · Cardiovascular device
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Jul 1985
Decision
91d
Days
Class 2
Risk

K851458 is an FDA 510(k) clearance for the MODEL 493-04 POLYFLEX R IMPLANTABLE PACING LEAD. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Intermedics, Inc. (Freeport, US). The FDA issued a Cleared decision on July 11, 1985 after a review of 91 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. 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 Intermedics, Inc. devices

FDA 510(k) Submission Details - K851458

510(k) Number K851458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1985
Decision Date July 11, 1985
Days to Decision 91 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
34d faster than avg
Panel avg: 125d · This submission: 91d
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 K851458.
MEDTRONIC MODEL 5561
K852356 · Medtronic Vascular · Aug 1985
329 CORDIS ENCOR PREVENOUS ARTRIAL & VENTRICULAR
K852253 · Cordis Corp. · Jul 1985
MODEL 483-06 POLYFLEX IMPLANTABLE PACING LEAD
K851457 · Intermedics, Inc. · Jul 1985
MEDTRONIC 5064
K851890 · Medtronic Vascular · Jun 1985
PACESETTER SYSTEMS, MODEL 458 ADAPTER SLEEVE
K851665 · Pacesetter Systems · May 1985
PACESETTER SYSTEMS INC. ENDOCARDIAL FINNED LEAD
K851145 · Pacesetter Systems · Apr 1985