Cleared Traditional

ACCUFIX AND LASERDISH BIPOLAR VS-1 LEADS (K884811) - FDA 510(k) Clearance

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

K884811 · Telectronics and Control Pacing Systems · Cardiovascular device
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Feb 1989
Decision
97d
Days
Class 3
Risk

K884811 is an FDA 510(k) clearance for the ACCUFIX AND LASERDISH BIPOLAR VS-1 LEADS. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Telectronics and Control Pacing Systems (Englewood, US). The FDA issued a Cleared decision on February 22, 1989 after a review of 97 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 Telectronics and Control Pacing Systems devices

Submission Details

510(k) Number K884811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1988
Decision Date February 22, 1989
Days to Decision 97 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 125d · This submission: 97d
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 K884811.
ALTERNATE PACKAGING CONFIGURATION FOR PACING LEADS
K890527 · Medtronic Vascular · Apr 1989
MODELS 432-03 & 433-03 IMPLANTABLE PACING LEADS
K890411 · Intermedics, Inc. · Mar 1989
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