Cleared Traditional

K802295 - POLY FLEX IMPLANTABLE PACING LEAD

K802295 is an FDA 510(k) clearance for POLY FLEX IMPLANTABLE PACING LEAD, manufactured by Intermedics, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K802295 · Intermedics, Inc. · Cardiovascular device
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Feb 1981
Decision
143d
Days
Class 3
Risk

K802295 is an FDA 510(k) clearance for the POLY FLEX IMPLANTABLE PACING LEAD. 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 February 9, 1981 after a review of 143 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K802295

510(k) Number K802295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1980
Decision Date February 09, 1981
Days to Decision 143 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
18d slower than avg
Panel avg: 125d · This submission: 143d
Pathway characteristics
Predicate-based equivalence.

DTB Device Classification - Class 3, Premarket Approval

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 396
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K802295.
TEMPORARY MYOCARDIAL PACING LEAD#6400
K810333 · Medtronic Vascular · Mar 1981
CORDIS PERVENOUS ATRIAL LEAD
K810432 · Cordis Corp. · Mar 1981
ELECTRODE, PACEMAKER PERMANENT
K810582 · Pacesetter Systems · Mar 1981
CORDIS MULTIFILAR PERVENOUS VENTRIC. LD
K810202 · Cordis Corp. · Feb 1981
PERMANENT & TEMP. PACEMAKER ELECTRODE
K802547 · Daig Corp. · Jan 1981
PERM. ENDOCARDIAL UNIPOLAR TINED/WEDGE
K802552 · Daig Corp. · Jan 1981