Cleared Traditional

K834358 - PARALLEL DUAL LUMEN SUBCLAVIAN CANNULA

K834358 is an FDA 510(k) clearance for PARALLEL DUAL LUMEN SUBCLAVIAN CANNULA, manufactured by Vas-Cath of Canada , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FIQ cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K834358 · Vas-Cath of Canada , Ltd. · Gastroenterology & Urology device
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Apr 1984
Decision
111d
Days
Class 2
Risk

K834358 is an FDA 510(k) clearance for the PARALLEL DUAL LUMEN SUBCLAVIAN CANNULA. Classified as Cannula, A-v Shunt (product code FIQ), Class II - Special Controls.

Submitted by Vas-Cath of Canada , Ltd. (Mchenry, US). The FDA issued a Cleared decision on April 2, 1984 after a review of 111 days - within the typical 510(k) review window.

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 of Canada , Ltd. devices

FDA 510(k) Submission Details - K834358

510(k) Number K834358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1983
Decision Date April 02, 1984
Days to Decision 111 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
20d faster than avg
Panel avg: 131d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FIQ Device Classification - Class 2, Special Controls

Product Code FIQ Cannula, A-v Shunt
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 - FIQ Cannula, A-v Shunt

All 18
Devices cleared under the same product code (FIQ) and FDA review panel - the closest regulatory comparables to K834358.
PLUME FISTULA NEEDLE
K841791 · Hospal Medical Corp. · Jul 1984
HEMOFILTRATION CATHETER HF-100
K840322 · Vas-Cath of Canada , Ltd. · Apr 1984
HEMOCATH
K840415 · Quinton, Inc. · Apr 1984
HEMASITE/RENALOY -VASCULAR ACCESS SHUNT
K840436 · Renal Systems, Inc. · Feb 1984
RENALLOY HEMASITE VASCULAR ACCESS SHUNT
K833622 · Renal Systems, Inc. · Nov 1983
EXTRACORPOREAL SUBCLAVIAN CATHETER KIT
K823752 · Extracorporeal Medical Specialities, Inc. · Jan 1983