Cleared Traditional

POLY-FLEX PACING LEADS (K813028) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K813028 · Intermedics, Inc. · Cardiovascular device
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Dec 1981
Decision
43d
Days
Class 3
Risk

K813028 is an FDA 510(k) clearance for the POLY-FLEX PACING LEADS. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Intermedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 10, 1981 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - 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 Intermedics, Inc. devices

Submission Details

510(k) Number K813028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1981
Decision Date December 10, 1981
Days to Decision 43 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
82d faster than avg
Panel avg: 125d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DTB Permanent Pacemaker Electrode
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3680
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 - DTB Permanent Pacemaker Electrode

All 221
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K813028.
POROUS SURFACED PLATINUM IRIDIUM
K821889 · Cordis Corp. · Aug 1982
IMPLANTIBLE SUTURE SLEEVE
K820487 · Intermedics, Inc. · Apr 1982
LASERPOR AP ATRIAL ENDOCARD. ELECTR. LD.
K820121 · Telectronics, Inc. · Feb 1982
ATRIAL ENDOCARDIAL ELECTRODE LEAD J-TIP
K813134 · Telectronics, Inc. · Dec 1981
INTERMEDICS POLYFLEX-MODEL 493-03 LEAD
K812989 · Intermedics, Inc. · Nov 1981
INTERMEDICS POLYFLEX-MODEL 483-03 LEAD
K812990 · Intermedics, Inc. · Nov 1981