Cleared Traditional

K820989 - MEDTRONIC #6993

K820989 is the FDA 510(k) clearance for MEDTRONIC #6993 by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K820989 · Medtronic Vascular · Cardiovascular device
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Aug 1982
Decision
121d
Days
Class 3
Risk

K820989 is an FDA 510(k) clearance for the MEDTRONIC #6993. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on August 6, 1982 after a review of 121 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 Medtronic Vascular devices

Submission Details

510(k) Number K820989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1982
Decision Date August 06, 1982
Days to Decision 121 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
4d faster than avg
Panel avg: 125d · This submission: 121d
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 K820989.
PRODUCTS IMPLANTABLE PACING LEAD,TINED
K823446 · Oscor, Inc. · Dec 1982
IMPLANTABLE PACING LEAD TINED #3390 &
K823448 · Oscor, Inc. · Dec 1982
MEDTRONIC MODELS 4011 & 4511
K822781 · Medtronic Vascular · Nov 1982
POROUS SURFACED PLATINUM IRIDIUM
K821889 · Cordis Corp. · Aug 1982
FASTPASS IMPLANTABLE ENDOCARD. PACING
K821947 · Pacesetter Systems · Aug 1982
IMPLANTIBLE SUTURE SLEEVE
K820487 · Intermedics, Inc. · Apr 1982