Cleared Traditional

K030502 - 14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55

K030502 is an FDA 510(k) clearance for 14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CAT..., manufactured by Medcomp. The device is a Class 2 Gastroenterology & Urology device with product code MSD cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K030502 · Medcomp · Gastroenterology & Urology device
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May 2003
Decision
90d
Days
Class 2
Risk

K030502 is an FDA 510(k) clearance for the 14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55. Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Medcomp (Harleysville, US). The FDA issued a Cleared decision on May 20, 2003 after a review of 90 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 Medcomp devices

FDA 510(k) Submission Details - K030502

510(k) Number K030502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2003
Decision Date May 20, 2003
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 131d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSD Device Classification - Class 2, Special Controls

Product Code MSD Catheter, Hemodialysis, Implanted
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 - MSD Catheter, Hemodialysis, Implanted

All 83
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K030502.
VAXCEL PLUS CHRONIC DIALYSIS CATHETER
K032712 · Boston Scientific Corp · Oct 2003
SOFT-CELL DUAL LUMEN CATHETERS
K030277 · C.R. Bard, Inc. · Aug 2003
HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER
K030020 · C.R. Bard, Inc. · Jun 2003
DIATEK CANNON-CATHETER, MODEL CC5500
K022662 · Arrow Intl., Inc. · May 2003
MEDCOMP SC4
K022678 · Medcomp · Feb 2003
LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER
K022905 · Horizon Medical Products, Inc. · Dec 2002