Cleared Traditional

K842577 - CATH-TECH POLYURETHANE UMBILICAL VESS

K842577 is an FDA 510(k) clearance for CATH-TECH POLYURETHANE UMBILICAL VESS, manufactured by Catheter Technology Corp.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K842577 · Catheter Technology Corp. · General Hospital
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Mar 1985
Decision
253d
Days
Class 2
Risk

K842577 is an FDA 510(k) clearance for the CATH-TECH POLYURETHANE UMBILICAL VESS. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Catheter Technology Corp. (Salt Lake City, US). The FDA issued a Cleared decision on March 13, 1985 after a review of 253 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 Catheter Technology Corp. devices

FDA 510(k) Submission Details - K842577

510(k) Number K842577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1984
Decision Date March 13, 1985
Days to Decision 253 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
124d slower than avg
Panel avg: 129d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FOZ Device Classification - Class 2, Special Controls

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 417
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K842577.
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QUINTON WHITE SEALING CAP
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DESERET INTRAVASCULAR CATHETER
K843033 · Parke-Davis Co. · Dec 1984
DESERET SUBCLAVIAN JUGULAR CATHETER SET
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