Cleared Traditional

K860810 - MEDCOMP'S FEMORAL VEIN CATHETERS

K860810 is an FDA 510(k) clearance for MEDCOMP'S FEMORAL VEIN CATHETERS, manufactured by Medical Components, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LFK cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K860810 · Medical Components, Inc. · Gastroenterology & Urology device
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Apr 1986
Decision
35d
Days
Class 2
Risk

K860810 is an FDA 510(k) clearance for the MEDCOMP'S FEMORAL VEIN CATHETERS. Classified as Catheter, Femoral (product code LFK), Class II - Special Controls.

Submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on April 8, 1986 after a review of 35 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 Medical Components, Inc. devices

FDA 510(k) Submission Details - K860810

510(k) Number K860810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1986
Decision Date April 08, 1986
Days to Decision 35 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
95d faster than avg
Panel avg: 130d · This submission: 35d
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 12
Devices cleared under the same product code (LFK) and FDA review panel - the closest regulatory comparables to K860810.
NEW SECOND FRENCH SIZE MAHURKAR CATHETER
K865096 · Quinton, Inc. · Feb 1987
CYTOSTATIC FILTRATION SET
K863218 · Meadox Surgimed, Inc. · Feb 1987
MEDCOMP C.A.V.H. CATHETER
K862771 · Medical Components, Inc. · Aug 1986
MAHURKAR FEMORAL CATHETER
K830674 · Quinton, Inc. · May 1983
COBE ACUFLEX FSN, #15-208
K820237 · Cobe Laboratories, Inc. · Mar 1982