Cleared Traditional

K874183 - ACTIFIX BIPOLAR ENDOCARDIAL SCREW-IN LEAD

K874183 is the FDA 510(k) clearance for ACTIFIX BIPOLAR ENDOCARDIAL SCREW-IN LEAD by Daig Corp.. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K874183 · Daig Corp. · Cardiovascular device
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Jan 1988
Decision
108d
Days
Class 3
Risk

K874183 is an FDA 510(k) clearance for the ACTIFIX (R) BIPOLAR ENDOCARDIAL SCREW-IN LEAD. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Daig Corp. (Minnetonka, US). The FDA issued a Cleared decision on January 29, 1988 after a review of 108 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 Daig Corp. devices

Submission Details

510(k) Number K874183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1987
Decision Date January 29, 1988
Days to Decision 108 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
17d faster than avg
Panel avg: 125d · This submission: 108d
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 386
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K874183.
PERMANENT MYOCARDIAL LEADS MP SERIES
K872971 · Oscor Medical Corp. · Feb 1988
MEDTRONIC MODEL 4016A ENDOCARDIAL PACING LEAD
K873962 · Medtronic Vascular · Feb 1988
ENDOCARDIAL SCREW-IN LEAD, MODEL 1018T
K874205 · Pacesetter Systems · Feb 1988
MODEL 5013 TRANSVENOUS VENTRICULAR PACING LEAD
K874792 · Medtronic Vascular · Jan 1988
POLYFLEX(R) EPICARDIAL 439-04 IMPLANT PACING LEAD
K874531 · Intermedics, Inc. · Jan 1988
MODEL 366-12 ADAPTAID(TM) STEP-DOWN ADAPTER
K874930 · Intermedics, Inc. · Jan 1988