Cleared Traditional

MODEL 483-06 POLYFLEX IMPLANTABLE PACING LEAD (K851457) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K851457 · Intermedics, Inc. · Cardiovascular device
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Jul 1985
Decision
91d
Days
Class 2
Risk

K851457 is an FDA 510(k) clearance for the MODEL 483-06 POLYFLEX 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

Submission Details

510(k) Number K851457 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.

Device Classification

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 44
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K851457.
MEDTRONIC MODEL 4016 BIPOLAR ENDOCARDIAL SCREW-IN
K850968 · Medtronic Vascular · Aug 1985
MEDTRONIC MODEL 5561
K852356 · Medtronic Vascular · Aug 1985
329 CORDIS ENCOR PREVENOUS ARTRIAL & VENTRICULAR
K852253 · Cordis Corp. · Jul 1985
MODEL 493-04 POLYFLEX R IMPLANTABLE PACING LEAD
K851458 · Intermedics, Inc. · Jul 1985
MEDTRONIC 5064
K851890 · Medtronic Vascular · Jun 1985
MEDTRONIC 5061 ENDOCARDIAL PACING LEAD
K844974 · Medtronic Vascular · Mar 1985