Cleared Traditional

K781776 - PACING LEADS MODEL UL-811 AND UL-813

K781776 is the FDA 510(k) clearance for PACING LEADS MODEL UL-811 AND UL-813 by Pacesetter Systems. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K781776 · Pacesetter Systems · Cardiovascular device
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Oct 1978
Decision
14d
Days
Class 3
Risk

K781776 is an FDA 510(k) clearance for the PACING LEADS MODEL UL-811 AND UL-813. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Pacesetter Systems (Mchenry, US). The FDA issued a Cleared decision on October 27, 1978 after a review of 14 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 Pacesetter Systems devices

Submission Details

510(k) Number K781776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1978
Decision Date October 27, 1978
Days to Decision 14 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
111d faster than avg
Panel avg: 125d · This submission: 14d
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 K781776.
LEAD, SUTURELESS MYOCARDIAL
K782087 · Daig Corp. · Jan 1979
LEAD, TIMED PACING, IMPLANTABLE
K782004 · Daig Corp. · Dec 1978
ELECTRODES, IMPLANTABLE WITH ADAPTER
K781849 · Telectronics, Inc. · Dec 1978
PACEMAKER, ELECTRODE, PERMANENT & TEMP.
K780246 · Daig Corp. · Aug 1978
BIPOLAR ENDOCARDIAL PACING LEAD, M. 6902
K780622 · Medtronic Vascular · Jul 1978
ENDOCARDIAL ATRIAL PACING LEAD, M. 6994
K780623 · Medtronic Vascular · Jul 1978