Cleared Traditional

K850460 - VIGGO SECALON T CATHETER

K850460 is an FDA 510(k) clearance for VIGGO SECALON T CATHETER, manufactured by Viggo Products. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K850460 · Viggo Products · General Hospital
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Apr 1985
Decision
64d
Days
Class 2
Risk

K850460 is an FDA 510(k) clearance for the VIGGO SECALON T CATHETER. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Viggo Products (Madison, US). The FDA issued a Cleared decision on April 11, 1985 after a review of 64 days - a notably fast clearance 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: 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 Viggo Products devices

FDA 510(k) Submission Details - K850460

510(k) Number K850460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1985
Decision Date April 11, 1985
Days to Decision 64 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
65d faster than avg
Panel avg: 129d · This submission: 64d
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 428
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K850460.
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K843033 · Parke-Davis Co. · Dec 1984
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K844113 · Parke-Davis Co. · Nov 1984