Cleared Traditional

K882466 - VAS-CATH PEDIATRIC HEMOFILTRATION CATHETER

K882466 is an FDA 510(k) clearance for VAS-CATH PEDIATRIC HEMOFILTRATION CATHETER, manufactured by Vas-Cath, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LFK cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K882466 · Vas-Cath, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jul 1988
Decision
28d
Days
Class 2
Risk

K882466 is an FDA 510(k) clearance for the VAS-CATH PEDIATRIC HEMOFILTRATION CATHETER. Classified as Catheter, Femoral (product code LFK), Class II - Special Controls.

Submitted by Vas-Cath, Inc. (Mississauga, Ontario, CA). The FDA issued a Cleared decision on July 13, 1988 after a review of 28 days - a notably fast clearance 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: 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 Vas-Cath, Inc. devices

FDA 510(k) Submission Details - K882466

510(k) Number K882466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1988
Decision Date July 13, 1988
Days to Decision 28 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
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFK Device Classification - Class 2, Special Controls

Product Code LFK Catheter, Femoral
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 - LFK Catheter, Femoral

All 11
Devices cleared under the same product code (LFK) and FDA review panel - the closest regulatory comparables to K882466.
FC-101 FEMORAL CATHETER GUIDE WIRE
K891764 · Akcess Medical Products, Inc. · Apr 1989
MODIFICATION HEMOFILTRATION CATHETER HF-100
K890717 · Vas-Cath, Inc. · Apr 1989
CONTINUOUS ARTERIAL/VENOUS HEMOFILTRATION TRAY
K880775 · Medsurg Industries, Inc. · Jul 1988
NEW SECOND FRENCH SIZE MAHURKAR CATHETER
K865096 · Quinton, Inc. · Feb 1987
MEDCOMP C.A.V.H. CATHETER
K862771 · Medical Components, Inc. · Aug 1986
MEDCOMP'S FEMORAL VEIN CATHETERS
K860810 · Medical Components, Inc. · Apr 1986