Cleared Traditional

K931587 - MULTI-PORT Y INTRODUCER SET

K931587 is the FDA 510(k) clearance for MULTI-PORT Y INTRODUCER SET by Thomas Medical Products, Inc.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K931587 · Thomas Medical Products, Inc. · Cardiovascular device
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Oct 1993
Decision
189d
Days
Class 2
Risk

K931587 is an FDA 510(k) clearance for the MULTI-PORT Y INTRODUCER SET. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Thomas Medical Products, Inc. (Malvern, US). The FDA issued a Cleared decision on October 6, 1993 after a review of 189 days - an extended review cycle.

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 Thomas Medical Products, Inc. devices

Submission Details

510(k) Number K931587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1993
Decision Date October 06, 1993
Days to Decision 189 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
64d slower than avg
Panel avg: 125d · This submission: 189d
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 372
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K931587.
ACS ROTATING HEMOSTATIC VALVE & ACS DUOSTAT ROTATING HEMOSTATIC VALVE
K934624 · Advanced Cardiovascular Systems, Inc. · Apr 1994
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BURRON CARDIOVASCULAR ANGESTAT(TM)
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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