Cleared Traditional

K870824 - ADDITIONAL CARDIAC PACING LEADS #1020 THROUGH 1035

K870824 is an FDA 510(k) clearance for ADDITIONAL CARDIAC PACING LEADS #1020 T..., manufactured by Pacesetter Systems. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K870824 · Pacesetter Systems · Cardiovascular device
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Mar 1987
Decision
66d
Days
Class 3
Risk

K870824 is an FDA 510(k) clearance for the ADDITIONAL CARDIAC PACING LEADS #1020 THROUGH 1035. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Pacesetter Systems (Sylmar, US). The FDA issued a Cleared decision on March 20, 1987 after a review of 66 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

FDA 510(k) Submission Details - K870824

510(k) Number K870824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1987
Decision Date March 20, 1987
Days to Decision 66 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
59d faster than avg
Panel avg: 125d · This submission: 66d
Pathway characteristics
Predicate-based equivalence.

DTB Device Classification - Class 3, Premarket Approval

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 423
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K870824.
IMPLANTABLE TINED, TRANS. PACING LEAD/REVIS. LABEL
K871333 · Medtronic Vascular · May 1987
MODEL 435-03 SIDE HOOK IMPLANTABLE PACING LEAD
K870948 · Intermedics, Inc. · Apr 1987
RESUBMISSION OF MODEL 030-437 IMPLANT. ELECTRODE
K870610 · Telectronics, Inc. · Mar 1987
MODEL PY...U UNIPOLAR & BIPOLAR PACING LEAD
K870034 · Oscor Medical Corp. · Mar 1987
MODEL 366-13 ADAPTAID STEP DOWN ADAPTER
K864326 · Intermedics, Inc. · Jan 1987
MODEL 436-01 BIOPORE IMPLANTABLE PACING LEAD
K862051 · Intermedics, Inc. · Jan 1987