Cleared Traditional

K935380 - VASCULAR ACCESS CATHETER ACCESSORIES

K935380 is the FDA 510(k) clearance for VASCULAR ACCESS CATHETER ACCESSORIES by Bard Access Systems, Inc.. It is a Class 2 General Hospital device (product code LJS) cleared through the Traditional 510(k) pathway after a 466-day FDA review.

K935380 · Bard Access Systems, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Feb 1995
Decision
466d
Days
Class 2
Risk

K935380 is an FDA 510(k) clearance for the VASCULAR ACCESS CATHETER ACCESSORIES. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Bard Access Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on February 17, 1995 after a review of 466 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 Bard Access Systems, Inc. devices

Submission Details

510(k) Number K935380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1993
Decision Date February 17, 1995
Days to Decision 466 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
337d slower than avg
Panel avg: 129d · This submission: 466d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 181
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K935380.
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