Cleared Traditional

K831997 - IMPLANTABLE ENDOCARDIAL PACING LEADS

K831997 is an FDA 510(k) clearance for IMPLANTABLE ENDOCARDIAL 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 121-day FDA review.

K831997 · Oscor, Inc. · Cardiovascular device
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Oct 1983
Decision
121d
Days
Class 3
Risk

K831997 is an FDA 510(k) clearance for the IMPLANTABLE ENDOCARDIAL 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 October 20, 1983 after a review of 121 days - within the typical 510(k) review window.

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 - K831997

510(k) Number K831997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1983
Decision Date October 20, 1983
Days to Decision 121 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
4d faster than avg
Panel avg: 125d · This submission: 121d
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 K831997.
CCS MODEL AV-102 IMPLANTABLE A-V DATA
K834342 · Cardiac Control Systems, Inc. · Feb 1984
ELECTRODE LEAD CONSTRUCTION
K834533 · Telectronics, Inc. · Jan 1984
ENDOCARDIAL SCREW-IN LEAD 859 & 861
K833824 · Pacesetter Systems · Dec 1983
PERMANTHANE #866 BIPOLAR COAXIAL
K832987 · Pacesetter Systems · Oct 1983
BIOTRONIK N, BIPOLAR PEB-60/4-N
K833099 · Biotronik Sales, Inc. · Oct 1983
BIOTRONIK DFH UNIPOLAR PE-60/4-DFH
K833106 · Biotronik Sales, Inc. · Oct 1983