Cleared Traditional

K823790 - VENTRICULAR ACCESS SYSTEM

K823790 is an FDA 510(k) clearance for VENTRICULAR ACCESS SYSTEM, manufactured by American Heyer Schulte. The device is a Class 2 General Hospital device with product code LKG cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K823790 · American Heyer Schulte · General Hospital
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Apr 1983
Decision
133d
Days
Class 2
Risk

K823790 is an FDA 510(k) clearance for the VENTRICULAR ACCESS SYSTEM. Classified as Port & Catheter, Implanted, Subcutaneous, Intraventricular (product code LKG), Class II - Special Controls.

Submitted by American Heyer Schulte (Mchenry, US). The FDA issued a Cleared decision on April 28, 1983 after a review of 133 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 882.5550 - 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 American Heyer Schulte devices

FDA 510(k) Submission Details - K823790

510(k) Number K823790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1982
Decision Date April 28, 1983
Days to Decision 133 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
4d slower than avg
Panel avg: 129d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKG Device Classification - Class 2, Special Controls

Product Code LKG Port & Catheter, Implanted, Subcutaneous, Intraventricular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5550
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.