Cleared Traditional

K843090 - UNIVERSITY OF CHICAGO VASCULAR ANGIOGRAM

K843090 is the FDA 510(k) clearance for UNIVERSITY OF CHICAGO VASCULAR ANGIOGRAM by Geneva Laboratories, Inc.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K843090 · Geneva Laboratories, Inc. · General Hospital
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Dec 1984
Decision
120d
Days
Class 2
Risk

K843090 is an FDA 510(k) clearance for the UNIVERSITY OF CHICAGO VASCULAR ANGIOGRAM. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Geneva Laboratories, Inc. (Elkhorn, US). The FDA issued a Cleared decision on December 4, 1984 after a review of 120 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 Geneva Laboratories, Inc. devices

Submission Details

510(k) Number K843090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1984
Decision Date December 04, 1984
Days to Decision 120 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
9d faster than avg
Panel avg: 129d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

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