Cleared Traditional

K801455 - LEAD

K801455 is the FDA 510(k) clearance for LEAD by Pacesetter Systems. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K801455 · Pacesetter Systems · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1980
Decision
121d
Days
Class 3
Risk

K801455 is an FDA 510(k) clearance for the LEAD, ENDOCARDIAL, TINED, BIPOLAR, 5MM. 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 23, 1980 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 Pacesetter Systems devices

Submission Details

510(k) Number K801455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1980
Decision Date October 23, 1980
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 K801455.
PACEPATH MODEL 810
K801416 · Pacesetter Systems · Oct 1980
POLYFLEX IMPLANTABLE PACING LEAD
K802293 · Intermedics, Inc. · Oct 1980
PACEPATH MODEL 819
K801417 · Pacesetter Systems · Oct 1980
IMPLANTABLE ENDOCARDIAL POROUS TIP ELEC.
K801792 · Telectronics, Inc. · Oct 1980
MEDTRONIC MODEL 69575
K800944 · Medtronic Vascular · Sep 1980
PERMANENT & TEMP. PACEMAKER ELECTRODE
K800795 · Daig Corp. · Jun 1980