Cleared Traditional

K890717 - MODIFICATION HEMOFILTRATION CATHETER HF-100

K890717 is an FDA 510(k) clearance for MODIFICATION HEMOFILTRATION CATHETER HF-100, 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 51-day FDA review.

K890717 · Vas-Cath, Inc. · Gastroenterology & Urology device
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Apr 1989
Decision
51d
Days
Class 2
Risk

K890717 is an FDA 510(k) clearance for the MODIFICATION HEMOFILTRATION CATHETER HF-100. 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 April 5, 1989 after a review of 51 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 - K890717

510(k) Number K890717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1989
Decision Date April 05, 1989
Days to Decision 51 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
79d faster than avg
Panel avg: 130d · This submission: 51d
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 K890717.
CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH. KITS
K915215 · Akcess Medical Products, Inc. · Mar 1992
FC-100 FEMORAL CATHETER
K891763 · Akcess Medical Products, Inc. · Apr 1989
FC-101 FEMORAL CATHETER GUIDE WIRE
K891764 · Akcess Medical Products, Inc. · Apr 1989
CONTINUOUS ARTERIAL/VENOUS HEMOFILTRATION TRAY
K880775 · Medsurg Industries, Inc. · Jul 1988
VAS-CATH PEDIATRIC HEMOFILTRATION CATHETER
K882466 · Vas-Cath, Inc. · Jul 1988
NEW SECOND FRENCH SIZE MAHURKAR CATHETER
K865096 · Quinton, Inc. · Feb 1987