Cleared Traditional

K864738 - MODEL 366-14 INTERMEDICS LEAD CONNECTOR CAP

K864738 is an FDA 510(k) clearance for MODEL 366-14 INTERMEDICS LEAD CONNECTOR CAP, manufactured by Intermedics, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K864738 · Intermedics, Inc. · Cardiovascular device
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Jan 1987
Decision
33d
Days
Class 3
Risk

K864738 is an FDA 510(k) clearance for the MODEL 366-14 INTERMEDICS LEAD CONNECTOR CAP. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Intermedics, Inc. (Freeport, US). The FDA issued a Cleared decision on January 6, 1987 after a review of 33 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 Intermedics, Inc. devices

FDA 510(k) Submission Details - K864738

510(k) Number K864738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1986
Decision Date January 06, 1987
Days to Decision 33 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
92d faster than avg
Panel avg: 125d · This submission: 33d
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 K864738.
MEDTRONIC MODEL 5013
K863536 · Medtronic Vascular · Jan 1987
CCS POLYSAFE(TM) ENDOCARDIAL PACING LEAD
K864601 · Cardiac Control Systems, Inc. · Jan 1987
ANCOR PERVENOUS ACTIVE FIXATION UNIPOLAR LEAD
K864640 · Cordis Corp. · 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
MODEL 366-23 ADAPTAID(TM) STEP-DOWN ADAPTER
K864428 · Intermedics, Inc. · Dec 1986