Cleared Traditional

K033719 - BARD TIGERTAIL URETERAL CATHETER

K033719 is an FDA 510(k) clearance for BARD TIGERTAIL URETERAL CATHETER, manufactured by C.R. Bard, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K033719 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
70d
Days
Class 2
Risk

K033719 is an FDA 510(k) clearance for the BARD TIGERTAIL URETERAL CATHETER. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on February 4, 2004 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K033719

510(k) Number K033719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2003
Decision Date February 04, 2004
Days to Decision 70 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 131d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOD Device Classification - Class 2, Special Controls

Product Code KOD Catheter, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KOD Catheter, Urological

All 154
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K033719.
BACKSTOP CATHETER
K103349 · Pluromed, Inc. · Jan 2011
IMAGER II UROLOGY TORQUE CATHETER (C1 TIP)
K102527 · Boston Scientific Corporation · Nov 2010
DOVER RED RUBBER ROBINSON CATHETER
K041243 · Tyco Healthcare · Jul 2004
INTERMITTENT URETHRAL CATHETERS
K033023 · Rusch Intl. · Dec 2003
URETERAL ACCESS SHEATH SET (UASS)
K022135 · Boston Scientific Corp · Sep 2002
INCARE ADVANCE
K013483 · Hollister, Inc. · Jan 2002