Cleared Abbreviated

K030268 - NIAGARA TEMPORARY DUAL LUMEN CATHETERS

Also marketed or referenced as:
FLEXXICON II TEMPORARY DUAL LUMEN CATHETERS

K030268 is an FDA 510(k) clearance for NIAGARA TEMPORARY DUAL LUMEN CATHETERS, manufactured by C.R. Bard, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code MPB cleared through the Abbreviated 510(k) pathway after a 184-day FDA review.

K030268 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
184d
Days
Class 2
Risk

K030268 is an FDA 510(k) clearance for the NIAGARA TEMPORARY DUAL LUMEN CATHETERS. Classified as Catheter, Hemodialysis, Non-implanted (product code MPB), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on July 30, 2003 after a review of 184 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - the FDA gastroenterology and urology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K030268

510(k) Number K030268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2003
Decision Date July 30, 2003
Days to Decision 184 days
Submission Type Abbreviated
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
53d slower than avg
Panel avg: 131d · This submission: 184d
Pathway characteristics
Standards-based clearance path.

MPB Device Classification - Class 2, Special Controls

Product Code MPB Catheter, Hemodialysis, Non-implanted
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
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 - MPB Catheter, Hemodialysis, Non-implanted

All 37
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K030268 · NIAGARA TEMPORARY DUAL LUMEN CATHETERS
Download PDF FDA Summary C.R. Bard, Inc.