Cleared Traditional

POLYSAFE CCS TRIFIX ENDOCARDIAL PACING LEAD SV-107 (K853446) - FDA 510(k) Clearance

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

K853446 · Cardiac Control Systems, Inc. · Cardiovascular device
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Jan 1986
Decision
150d
Days
Class 3
Risk

K853446 is an FDA 510(k) clearance for the POLYSAFE CCS TRIFIX ENDOCARDIAL PACING LEAD SV-107. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Cardiac Control Systems, Inc. (Palm Coast, US). The FDA issued a Cleared decision on January 13, 1986 after a review of 150 days - an extended review 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 Cardiac Control Systems, Inc. devices

Submission Details

510(k) Number K853446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1985
Decision Date January 13, 1986
Days to Decision 150 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 125d · This submission: 150d
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 187
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K853446.
MODEL 366-09 ADAPTAID ADAPTER SLEEVE
K860986 · Intermedics, Inc. · Mar 1986
MODEL 435-01 CARDIFIX IMPLANTABLE PACING LEAD
K854917 · Intermedics, Inc. · Mar 1986
MODEL 431-01 BIOPORE IMPLANTABLE PACING LEAD
K854918 · Intermedics, Inc. · Mar 1986
MOD TARGET/TIPS # 4011,4012,4511,4512,6912,4016
K854582 · Medtronic Vascular · Jan 1986
POLYFLEX 483-09 ENDOCARDIAL IMPLANTABLE PACINGLEAD
K854069 · Intermedics, Inc. · Dec 1985
MEDTRONIC MODEL 5062
K853398 · Medtronic Vascular · Dec 1985