Cleared Traditional

K801284 - LOW PROFILE LEAD CONNECTOR MODIFICATION...

K801284 is the FDA 510(k) clearance for LOW PROFILE LEAD CONNECTOR MODIFICATION... by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K801284 · Medtronic Vascular · Cardiovascular device
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Dec 1980
Decision
186d
Days
Class 3
Risk

K801284 is an FDA 510(k) clearance for the LOW PROFILE LEAD CONNECTOR MODIFICATION (4002). Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on December 1, 1980 after a review of 186 days - an extended review 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 Medtronic Vascular devices

Submission Details

510(k) Number K801284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1980
Decision Date December 01, 1980
Days to Decision 186 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 slower than avg
Panel avg: 125d · This submission: 186d
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 364
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K801284.
UNIPOLAR ENDOCARDIAL LASER DRILLED ELEC
K802968 · Telectronics, Inc. · Dec 1980
SIEMENS-ELEMA ENDOCARDIAL LEAD 402S
K803042 · Siemens Elema AB · Dec 1980
INTERMEDICS' LIFELINE TLE ENDOCARDIAL
K801172 · Intermedics, Inc. · Dec 1980
MEDTRONIC MODEL 6958
K800870 · Medtronic Vascular · Nov 1980
PACEPATH MODEL 810
K801416 · Pacesetter Systems · Oct 1980
POLYFLEX IMPLANTABLE PACING LEAD
K802293 · Intermedics, Inc. · Oct 1980