Cleared Traditional

K926293 - ANGIOCOR SIDEHOLE INFUSION CATHETER

K926293 is an FDA 510(k) clearance for ANGIOCOR SIDEHOLE INFUSION CATHETER, manufactured by Angiocor. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 448-day FDA review.

K926293 · Angiocor · General Hospital
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Mar 1994
Decision
448d
Days
Class 2
Risk

K926293 is an FDA 510(k) clearance for the ANGIOCOR SIDEHOLE INFUSION CATHETER. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Angiocor (Great Neck, US). The FDA issued a Cleared decision on March 7, 1994 after a review of 448 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Angiocor devices

FDA 510(k) Submission Details - K926293

510(k) Number K926293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1992
Decision Date March 07, 1994
Days to Decision 448 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
319d slower than avg
Panel avg: 129d · This submission: 448d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJS Device Classification - Class 2, Special Controls

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
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 - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 275
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