Cleared Traditional

PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F (K884394) - FDA 510(k) Clearance

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

K884394 · Ela Medical, Inc. · Cardiovascular device
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Dec 1988
Decision
55d
Days
Class 3
Risk

K884394 is an FDA 510(k) clearance for the PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Ela Medical, Inc. (Minnetonka, US). The FDA issued a Cleared decision on December 8, 1988 after a review of 55 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 Ela Medical, Inc. devices

Submission Details

510(k) Number K884394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1988
Decision Date December 08, 1988
Days to Decision 55 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 125d · This submission: 55d
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 K884394.
MODELS 430-07 & 431-07 IMPLANTABLE PACING LEADS
K890412 · Intermedics, Inc. · Mar 1989
MODEL 6208,6209,6210,6211,6212,6214 (PLI'S)
K890045 · Medtronic Vascular · Jan 1989
MEDTRONIC MODEL 4058 PACING LEAD
K883743 · Medtronic Vascular · Jan 1989
ENDOCARDIAL PACING LEADS-ANCHORING SLEEVE MODIFIED
K884005 · Medtronic Vascular · Dec 1988
MEDTRONIC MODEL 4951P
K881810 · Medtronic Vascular · Oct 1988
MODEL 5866-34A PACEMAKER LEAD ADAPTOR
K883203 · Medtronic Vascular · Sep 1988