Cleared Traditional

K802918 - ANTHRON CATHETER SET

K802918 is the FDA 510(k) clearance for ANTHRON CATHETER SET by National Catheter Co. Div. Mallinckrodt. It is a Class 2 General Hospital device (product code FOZ) cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K802918 · National Catheter Co. Div. Mallinckrodt · General Hospital
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Apr 1981
Decision
153d
Days
Class 2
Risk

K802918 is an FDA 510(k) clearance for the ANTHRON CATHETER SET. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by National Catheter Co. Div. Mallinckrodt (Mchenry, US). The FDA issued a Cleared decision on April 21, 1981 after a review of 153 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all National Catheter Co. Div. Mallinckrodt devices

Submission Details

510(k) Number K802918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1980
Decision Date April 21, 1981
Days to Decision 153 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 129d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 General Hospital devices follow this clearance model.

Regulatory Peers - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 148
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K802918.
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WHOLEY OCCLUSION BALLOON CATHETER
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I.V. START KIT
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NEEDLE CONNECTING SET, BLUNT
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