Cleared Traditional

K831767 - IMPLANTABLE CARDIAC PACING LEADS

K831767 is an FDA 510(k) clearance for IMPLANTABLE CARDIAC PACING LEADS, manufactured by Oscor, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K831767 · Oscor, Inc. · Cardiovascular device
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Jul 1983
Decision
55d
Days
Class 3
Risk

K831767 is an FDA 510(k) clearance for the IMPLANTABLE CARDIAC PACING LEADS. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on July 26, 1983 after a review of 55 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 Oscor, Inc. devices

FDA 510(k) Submission Details - K831767

510(k) Number K831767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1983
Decision Date July 26, 1983
Days to Decision 55 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
70d faster than avg
Panel avg: 125d · This submission: 55d
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 K831767.
UNIPOLAR-E ENDOCARDIAL TINED LEAD
K832245 · Cook Pacemaker Corp. · Aug 1983
MODEL F UNIPOLAR ENDOCARDIAL LEAD-
K832255 · Cook Pacemaker Corp. · Aug 1983
LIFELINE PACING LEADS #471-07 &09
K832409 · Intermedics, Inc. · Aug 1983
MEDTRONIC MODELS 4012 & 4512
K832099 · Medtronic Vascular · Jul 1983
CCS MODEL SJ-103 IMPLANTABLE ATRIAL
K831529 · Cardiac Control Systems, Inc. · Jun 1983
VENTRICULAR PACING LEADS MODELS 865/867
K831435 · Pacesetter Systems · Jun 1983