Cleared Traditional

K931662 - LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES

K931662 is an FDA 510(k) clearance for LEAD INTRODUCER SET, manufactured by Pace Medical. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K931662

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
Combination Product No
PCCP Authorized No
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.

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 604
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K931662.
MULTI-PORT Y INTRODUCER SET
K931587 · Thomas Medical Products, Inc. · Oct 1993
INTROPEEL
K930801 · Menlo Care, Inc. · Sep 1993
INTROPEEL V
K931218 · Menlo Care, Inc. · Sep 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