Cleared Traditional

K965178 - NIAGARA DUAL LUMEN CATHETER

K965178 is an FDA 510(k) clearance for NIAGARA DUAL LUMEN CATHETER, manufactured by Vas-Cath, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code MPB cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K965178 · Vas-Cath, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
238d
Days
Class 2
Risk

K965178 is an FDA 510(k) clearance for the NIAGARA DUAL LUMEN CATHETER. Classified as Catheter, Hemodialysis, Non-implanted (product code MPB), Class II - Special Controls.

Submitted by Vas-Cath, Inc. (Ontario, L5a 3v3, CA). The FDA issued a Cleared decision on August 19, 1997 after a review of 238 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 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Vas-Cath, Inc. devices

FDA 510(k) Submission Details - K965178

510(k) Number K965178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1996
Decision Date August 19, 1997
Days to Decision 238 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
108d slower than avg
Panel avg: 130d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 28
Devices cleared under the same product code (MPB) and FDA review panel - the closest regulatory comparables to K965178.
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K984022 · Arrow Intl., Inc. · May 1999
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K974236 · Medical Components, Inc. · Apr 1999
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K963446 · Kendall Healthcare Products Co. Div.Of Tyco Health · Mar 1997
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K952660 · B.Braun Medical, Inc. · Sep 1996
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K955002 · Quinton, Inc. · Sep 1996