Cleared Traditional

K004026 - BRAIDED GUIDING INTRODUCER

K004026 is an FDA 510(k) clearance for BRAIDED GUIDING INTRODUCER, 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 194-day FDA review.

K004026 · Thomas Medical Products, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
194d
Days
Class 2
Risk

K004026 is an FDA 510(k) clearance for the BRAIDED GUIDING INTRODUCER. 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 9, 2001 after a review of 194 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.

FDA 510(k) Submission Details - K004026

510(k) Number K004026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2000
Decision Date July 09, 2001
Days to Decision 194 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
69d slower than avg
Panel avg: 125d · This submission: 194d
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 695
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K004026.
MICROCRUISER PLUS INTRODUCER SET
K011790 · Medical Device Technologies, Inc. · Sep 2001
MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH DILATOR), MODELS PL-12-12-09, PL-12-12-10
K012489 · Appriva Medical, Inc. · Aug 2001
SPLITTABLE SHEATH INTRODUCER KIT
K004025 · 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
EMBOL-X INTRODUCER, MODEL CF00200
K002973 · Embol-X, Inc. · Apr 2001
K004026 · BRAIDED GUIDING INTRODUCER
Download PDF FDA Summary Thomas Medical Produc…