Cleared Traditional

CORDIS ANCOR ACTIVE FIXATION LEAD (K832422) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K832422 · Cordis Corp. · Cardiovascular device
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Aug 1986
Decision
1110d
Days
Class 3
Risk

K832422 is an FDA 510(k) clearance for the CORDIS ANCOR ACTIVE FIXATION LEAD. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Cordis Corp. (Miami, US). The FDA issued a Cleared decision on August 5, 1986 after a review of 1110 days - an unusually long review period, suggesting complex equivalence evaluation.

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. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Cordis Corp. devices

Submission Details

510(k) Number K832422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1983
Decision Date August 05, 1986
Days to Decision 1110 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
985d slower than avg
Panel avg: 125d · This submission: 1110d
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 221
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K832422.
MODEL 366-27 ADAPTAID(TM) STEP-DOWN ADAPTER
K864048 · Intermedics, Inc. · Nov 1986
MODEL 432-01 BIOPORE IMPLANTABLE PACING LEAD
K862053 · Intermedics, Inc. · Sep 1986
MODEL 430-01 BIOPORE IMPLANTABLE PACING LEAD
K862054 · Intermedics, Inc. · Sep 1986
CORDIS HI-FLEX PERVENOUS ACTIVE FIXATION UNIPOLAR
K851064 · Cordis Corp. · Aug 1986
IMPLANTABLE ELECTRODE LEAD, MODEL 030-436
K861767 · Telectronics, Inc. · Jul 1986
MODEL 431-02 BIOPORE IMPLANTABLE PACING LEAD
K862257 · Intermedics, Inc. · Jul 1986