Cleared Traditional

K884278 - IMPLANTABLE ELECTRODE LEADS 033-400

K884278 is an FDA 510(k) clearance for IMPLANTABLE ELECTRODE LEADS 033-400, manufactured by Telectronics, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K884278 · Telectronics, Inc. · Cardiovascular device
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Dec 1988
Decision
64d
Days
Class 3
Risk

K884278 is an FDA 510(k) clearance for the IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Telectronics, Inc. (Englewood, US). The FDA issued a Cleared decision on December 15, 1988 after a review of 64 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 Telectronics, Inc. devices

FDA 510(k) Submission Details - K884278

510(k) Number K884278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1988
Decision Date December 15, 1988
Days to Decision 64 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
61d faster than avg
Panel avg: 125d · This submission: 64d
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 387
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K884278.
VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE)
K890350 · Telectronics, Inc. · Feb 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
PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F
K884394 · Ela Medical, Inc. · Dec 1988
ENDOCARDIAL PACING LEADS-ANCHORING SLEEVE MODIFIED
K884005 · Medtronic Vascular · Dec 1988
PERMANENT PACING LEADS PYBJ SERIES
K882345 · Oscor Medical Corp. · Oct 1988