Cleared Traditional

K810333 - TEMPORARY MYOCARDIAL PACING LEAD#6400

K810333 is the FDA 510(k) clearance for TEMPORARY MYOCARDIAL PACING LEAD#6400 by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K810333 · Medtronic Vascular · Cardiovascular device
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Mar 1981
Decision
32d
Days
Class 3
Risk

K810333 is an FDA 510(k) clearance for the TEMPORARY MYOCARDIAL PACING LEAD#6400. 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 March 13, 1981 after a review of 32 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 Medtronic Vascular devices

Submission Details

510(k) Number K810333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1981
Decision Date March 13, 1981
Days to Decision 32 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
93d faster than avg
Panel avg: 125d · This submission: 32d
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 K810333.
TYPE YC ENDOCARDIAL LEAD
K810491 · Biotronik Sales, Inc. · Mar 1981
TYPE YR ENDOCARDIAL LEAD
K810492 · Biotronik Sales, Inc. · Mar 1981
TYPE N ENDOCARDIAL LEAD
K810493 · Biotronik Sales, Inc. · Mar 1981
CORDIS PERVENOUS ATRIAL LEAD
K810432 · Cordis Corp. · Mar 1981
ELECTRODE, PACEMAKER PERMANENT
K810582 · Pacesetter Systems · Mar 1981
POLY FLEX IMPLANTABLE PACING LEAD
K802295 · Intermedics, Inc. · Feb 1981