Cleared Traditional

K854069 - POLYFLEX 483-09 ENDOCARDIAL IMPLANTABLE...

K854069 is an FDA 510(k) clearance for POLYFLEX 483-09 ENDOCARDIAL IMPLANTABLE..., 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 66-day FDA review.

K854069 · Intermedics, Inc. · Cardiovascular device
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Dec 1985
Decision
66d
Days
Class 3
Risk

K854069 is an FDA 510(k) clearance for the POLYFLEX 483-09 ENDOCARDIAL IMPLANTABLE PACINGLEAD. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Intermedics, Inc. (Freeport, US). The FDA issued a Cleared decision on December 9, 1985 after a review of 66 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

FDA 510(k) Submission Details - K854069

510(k) Number K854069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1985
Decision Date December 09, 1985
Days to Decision 66 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
59d faster than avg
Panel avg: 125d · This submission: 66d
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 K854069.
STYLET INTRODUCER FUNNEL
K854142 · Telectronics, Inc. · Jan 1986
POLYSAFE CCS TRIFIX ENDOCARDIAL PACING LEAD SV-107
K853446 · Cardiac Control Systems, Inc. · Jan 1986
MOD TARGET/TIPS # 4011,4012,4511,4512,6912,4016
K854582 · Medtronic Vascular · Jan 1986
IMPLANT ELECT LEAD MOD 30-404 USING POLYU 90 A
K852710 · Telectronics, Inc. · Dec 1985
CCS MODEL BV-114 IMPLANTABLE ENDOCARDIAL BIPOLARPA
K853294 · Cardiac Control Systems, Inc. · Dec 1985
MEDTRONIC MODEL 5062
K853398 · Medtronic Vascular · Dec 1985