Cleared Traditional

K791411 - COAXIAL DUAL FLOW CATHETER

K791411 is the FDA 510(k) clearance for COAXIAL DUAL FLOW CATHETER by Terumo America, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KOC) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K791411 · Terumo America, Inc. · Gastroenterology & Urology device
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Nov 1979
Decision
109d
Days
Class 2
Risk

K791411 is an FDA 510(k) clearance for the COAXIAL DUAL FLOW CATHETER. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Terumo America, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 13, 1979 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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 Terumo America, Inc. devices

Submission Details

510(k) Number K791411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1979
Decision Date November 13, 1979
Days to Decision 109 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 130d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOC Accessories, Blood Circuit, Hemodialysis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 - KOC Accessories, Blood Circuit, Hemodialysis

All 118
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K791411.
BIONICS ARTERIAL/VENOUS FISTULA NEEDLE
K801354 · Cordis Corp. · Jul 1980
BIONICS BI-FLO STRETCH(DOUBLE LUMEN FOR
K801355 · Cordis Corp. · Jul 1980
BIONICS BI-FLO SAFE(DOUBLE LUMEN CATHET
K801356 · Cordis Corp. · Jul 1980
TG 2, TRI-GARD PRESSURE MONITOR
K790841 · Sorensen Research · Jun 1979
HEMODIALYSIS BLOOD CIRCUIT
K790591 · Travenol Laboratories, S.A. · May 1979
ARTERIOVENOUS SETS
K790381 · Extracorporeal Medical Specialities, Inc. · Apr 1979