Cleared Traditional

K931662 - LEAD INTRODUCER SET

K931662 is the FDA 510(k) clearance for LEAD INTRODUCER SET by Pace Medical. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K931662 · Pace Medical · Cardiovascular device
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Aug 1993
Decision
148d
Days
Class 2
Risk

K931662 is an FDA 510(k) clearance for the LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Pace Medical (Waltham, US). The FDA issued a Cleared decision on August 31, 1993 after a review of 148 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 Pace Medical devices

Submission Details

510(k) Number K931662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1993
Decision Date August 31, 1993
Days to Decision 148 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 125d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 392
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K931662.
ACS ROTATING HEMOSTATIC VALVE & ACS DUOSTAT ROTATING HEMOSTATIC VALVE
K934624 · Advanced Cardiovascular Systems, Inc. · Apr 1994
CATHETER INTRODUCER MODIFICATION
K934285 · Daig Corp. · Nov 1993
BURRON CARDIOVASCULAR ANGESTAT(TM)
K931743 · B.Braun Medical, Inc. · Nov 1993
CORDIS CATHETER SHEATH INTRODUCER
K932733 · Cordis Corp. · Aug 1993
ANGESTAT FLUORO-TIP HEMOSTASIS INTRODUCER SET
K930057 · B.Braun Medical, Inc. · Aug 1993
BALT INTRODUCER
K925633 · Target Therapeutics · Jun 1993