Cleared Traditional

K822781 - MEDTRONIC MODELS 4011 & 4511

K822781 is the FDA 510(k) clearance for MEDTRONIC MODELS 4011 & 4511 by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K822781 · Medtronic Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1982
Decision
77d
Days
Class 3
Risk

K822781 is an FDA 510(k) clearance for the MEDTRONIC MODELS 4011 & 4511. 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 November 30, 1982 after a review of 77 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 K822781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1982
Decision Date November 30, 1982
Days to Decision 77 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
48d faster than avg
Panel avg: 125d · This submission: 77d
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 K822781.
ELECTRODE, PACEMAKER, PERMANENT
K823033 · Pacesetter Systems · Dec 1982
PRODUCTS IMPLANTABLE PACING LEAD,TINED
K823446 · Oscor, Inc. · Dec 1982
IMPLANTABLE PACING LEAD TINED #3390 &
K823448 · Oscor, Inc. · Dec 1982
MEDTRONIC #6993
K820989 · Medtronic Vascular · Aug 1982
POROUS SURFACED PLATINUM IRIDIUM
K821889 · Cordis Corp. · Aug 1982
FASTPASS IMPLANTABLE ENDOCARD. PACING
K821947 · Pacesetter Systems · Aug 1982