Cleared Traditional

K772203 - VENTRICULAR LEADS

K772203 is the FDA 510(k) clearance for VENTRICULAR LEADS by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K772203 · Medtronic Vascular · Cardiovascular device
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Jan 1978
Decision
42d
Days
Class 3
Risk

K772203 is an FDA 510(k) clearance for the VENTRICULAR LEADS. 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 January 11, 1978 after a review of 42 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 K772203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1977
Decision Date January 11, 1978
Days to Decision 42 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
83d faster than avg
Panel avg: 125d · This submission: 42d
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 K772203.
LEAD, PACING, ATRIAL, ENDOCARDIAL, TINED
K780621 · Medtronic Vascular · Jul 1978
SUTURELESS MYOCARDIAL PACING LEAD
K780446 · Medtronic Vascular · May 1978
PACEMAKER, PERM. & TEMP., ELECTRODE
K772197 · Daig Corp. · Jan 1978
RESTERIL. OF IMPLANT. ELECT. & ADAPTER
K772331 · Telectronics, Inc. · Jan 1978
PACING LEAD MODEL 6991A
K772104 · Medtronic Vascular · Nov 1977
BIPOLAR LEADS, DISP.
K772103 · Medtronic Vascular · Nov 1977