Cleared Traditional

K831751 - LEAD INTRODUCER SETS-EB-S8 & EB-S12

K831751 is an FDA 510(k) clearance for LEAD INTRODUCER SETS-EB-S8 & EB-S12, manufactured by Oscor, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K831751 · Oscor, Inc. · Cardiovascular device
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Oct 1983
Decision
141d
Days
Class 2
Risk

K831751 is an FDA 510(k) clearance for the LEAD INTRODUCER SETS-EB-S8 & EB-S12. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on October 20, 1983 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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: Standard predicate-based submission. Standard predicate reliance. 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 - K831751

510(k) Number K831751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1983
Decision Date October 20, 1983
Days to Decision 141 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
16d slower than avg
Panel avg: 125d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DYB Introducer, Catheter

All 438
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K831751.
MEDTRONIC 6210 PERMANENT LEAD INTRODUC
K842780 · Medtronic Vascular · Aug 1984
EMERGENCY INFUSION DEVICE
K840455 · Arrow Intl., Inc. · May 1984
ANGIOGRAPHY NEEDLE W/WO CONNECTION
K840923 · Dlp, Inc. · Apr 1984
FRENCH PERCUTANEOUS SHEATH INTRODUCER
K830813 · Norton Performance Plastics Corp. · Apr 1983
CORONARY GUIDING CATHETER
K830829 · Advanced Cardiovascular Systems, Inc. · Apr 1983
MODEL SP5800 #8 FRENCH INTRO. KIT
K823262 · Gould, Inc. · Jan 1983