Cleared Traditional

K864640 - ANCOR PERVENOUS ACTIVE FIXATION UNIPOLA...

K864640 is an FDA 510(k) clearance for ANCOR PERVENOUS ACTIVE FIXATION UNIPOLA..., manufactured by Cordis Corp.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K864640 · Cordis Corp. · Cardiovascular device
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Jan 1987
Decision
41d
Days
Class 3
Risk

K864640 is an FDA 510(k) clearance for the ANCOR PERVENOUS ACTIVE FIXATION UNIPOLAR 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 January 6, 1987 after a review of 41 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 Cordis Corp. devices

FDA 510(k) Submission Details - K864640

510(k) Number K864640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1986
Decision Date January 06, 1987
Days to Decision 41 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
84d faster than avg
Panel avg: 125d · This submission: 41d
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 396
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K864640.
MODEL 436-01 BIOPORE IMPLANTABLE PACING LEAD
K862051 · Intermedics, Inc. · Jan 1987
MEDTRONIC MODEL 5013
K863536 · Medtronic Vascular · Jan 1987
CCS POLYSAFE(TM) ENDOCARDIAL PACING LEAD
K864601 · Cardiac Control Systems, Inc. · Jan 1987
MODEL 366-14 INTERMEDICS LEAD CONNECTOR CAP
K864738 · Intermedics, Inc. · Jan 1987
MODEL 5866-24 PACEMAKER LEAD ADAPTOR
K864856 · Medtronic Vascular · Jan 1987
TELECTRONICS SREW-IN/SLIM LINE PACING LEADS
K864098 · Daig Corp. · Dec 1986