Cleared Traditional

K004025 - SPLITTABLE SHEATH INTRODUCER KIT

K004025 is an FDA 510(k) clearance for SPLITTABLE SHEATH INTRODUCER KIT, manufactured by Thomas Medical Products, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K004025 · Thomas Medical Products, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
204d
Days
Class 2
Risk

K004025 is an FDA 510(k) clearance for the SPLITTABLE SHEATH INTRODUCER KIT. 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 July 19, 2001 after a review of 204 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

FDA 510(k) Submission Details - K004025

510(k) Number K004025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2000
Decision Date July 19, 2001
Days to Decision 204 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 125d · This submission: 204d
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 535
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K004025.
VYGON SPLIT CANNULA INTRODUCER
K010913 · Vygon Corp. · Sep 2001
ULTRAFLEX EV HEMOSTASIS INTRODUCER
K012922 · St Jude Medical · Sep 2001
MICROCRUISER PLUS INTRODUCER SET
K011790 · Medical Device Technologies, Inc. · Sep 2001
BRAIDED GUIDING INTRODUCER
K004026 · Thomas Medical Products, Inc. · Jul 2001
GUIDEWIRE INTRODUCER SAFETY NEEDLE
K011085 · Medamicus, Inc. · Jul 2001
INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX
K002847 · Maxxim Medical · May 2001